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    • Application(array)
      • id496
      • user_id73
      • trial_status_id5
      • abstract_of_study<p>\n Real-time electronic monitoring is the optimal approach for understanding patterns of adherence, which is critical for determining if adherence to daily oral pre-exposure prophylaxis (PrEP) aligns with an individual’s risk for HIV acquisition. Compared with earlier adherence measurement devices, next generation Wisepill technology offers significant innovations in data storage and transmission reliability, cost, and usability and is ready for implementation in resource-limited settings. Coupling Wisepill monitoring to SMS adherence reminders has great potential to support adherence at the precise time it is needed. Real-time strategies may be particularly important for young women- a population in need of self-controlled HIV prevention strategies, but one that has previously struggled with PrEP adherence. Triangulating weekly SMS measurement of sexual behavior with adherence may explain how PrEP can be used most effectively for HIV prevention (i.e., prevention-effective adherence).</p>\n<p>\n This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered PrEP for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive SMS reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.</p>\n<p>\n <strong>Design</strong>:  Prospective study of open-label PrEP</p>\n<p>\n                 Randomization (1:1) of SMS reminders on PrEP adherence</p>\n<p style=\"margin-left:.5in;\">\n Periodic surveys of risk behavior and perception, including by weekly SMS</p>\n<p style=\"margin-left:.5in;\">\n Two years of follow-up per participant</p>\n<p>\n <strong>Population: </strong>Young women at high risk for HIV infection who are interested in taking PrEP </p>\n
      • study_title<h3>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Next generation real-time monitoring for PrEP adherence in young Kenyan women</strong></span></h3>\n
      • laymans_summary<p>\n <span style=\"color: rgb(0, 0, 0); font-size: 11pt; font-family: Arial, sans-serif;\">Pre-Exposure Prophylaxis (PrEP) is a new anti-retroviral based HIV prevention method. It works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize strategies that will enhance compliance, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to an already-burdened public health infrastructure and the ability of health systems to maximize PrEP use will necessitate finding novel strategies that would encourage and enhance adherence. Additionally, there exist major barriers to PrEP use, which includes stigma, costs of staffing and healthcare providers’ unfamiliarity with delivering prevention interventions. </span><span style=\"color: rgb(0, 0, 0); font-family: Arial, sans-serif; font-size: 11pt;\">This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered PrEP for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive SMS reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women.</span></p>\n
      • short_titleMonitoring Pre-exposure Prophylaxis for Young Adult women (MPYA)
      • protocol_noECCT/16/05/02
      • version_no2.0
      • date_of_protocol19-04-2016
      • study_drugEmtricitabine/Tenofovir Disoproxil Fumarate (Truvada) - MPYA Study
      • disease_conditionPrEP for HIV Prevention in Young Women
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameEmtricitabine/Tenofovir Disoproxil Fumarate (Truvada)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
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      • applicant_approval_letter1
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      • applicant_participating_countries0
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      • applicant_indemnity_pi0
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      • applicant_hard_copies(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Kenneth Ngure
      • declaration_date117-05-2016
      • declaration_principal_investigatorDr Nelly R. Mugo
      • declaration_date217-05-2016
      • placebo_presentNo
      • study_objectives<p>\n <strong>Aim 1.</strong> <u>Use the next generation Wisepill device in a cohort of young HIV-uninfected Kenyan women initiating PrEP to a) measure real-time adherence and b) determine the impact of SMS reminders on adherence</u>. We will monitor adherence among all women with Wisepill. We will randomize half to receive daily SMS reminders with the option of switching to SMS reminders only as triggered by missed doses; the other half will receive no SMS reminders. There will be two primary outcomes for this aim. First, we will determine enacted adherence (i.e., pill taking) and persistence (i.e., continuation of PrEP over time) as determined by Wisepill from initiation of PrEP use (when adherence patterns are often established) through 24 months of use, comparing those randomized or not to SMS reminders. Second, we will compare dried blood spot (DBS) tenofovir-diphosphate levels between the two groups at multiple time points. With both outcomes, we will be assessing the synergy of SMS reminders coupled to real-time monitoring.</p>\n<p>\n  </p>\n<p>\n <strong>Aim 2. </strong><u>Determine the technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders.</u> We will measure data transmission reliability, battery life, and other technical features through the two-year cohort study. We will assess acceptability and usability of our strategy via quantitative surveys in all women, as well as qualitative interviews in about 50 women. We will additionally assess costs and ease of use with a time and motion study. Using these cost estimates and adapting an existing mathematical model of HIV transmission, we will estimate the cost-effectiveness of Wisepill plus the SMS reminders per HIV case averted. Adherence validity will be determined by comparing the Wisepill data with DBS tenofovir levels as measured in Aim 1. Discrepancies between the two measures will be explored through qualitative interviews at the conclusion of the study.</p>\n<p>\n  </p>\n<p>\n <strong>Aim 3. </strong><u>Triangulate Wisepill adherence data with weekly assessment of HIV risk behaviors and perceptions, to measure prevention-effective adherence.</u> After the first 6 months of PrEP use (i.e., when initial decisions about PrEP may start to change), we will send all women a weekly SMS survey asking about recent sexual behavior, use of alternate HIV prevention tools, subjective HIV risk, and perception of their PrEP adherence. We will explore the overlap of perceptions and behaviors and PrEP adherence, through quantitative surveys in all women and qualitative interviews in about 50 women. Our goal is to measure dynamic changes in HIV risk and perception of risk or other motivators for HIV prevention that may lead to PrEP discontinuation (appropriately or inappropriately). We will use these SMS surveys to quantify prevention-effective adherence in young women at risk for HIV infection (individually and for the cohort overall). At exit from the study, we will administer a short questionnaire to understand future plans to use PrEP and experiences related to PrEP during the study.</p>\n<p>\n  </p>\n<p>\n <strong>Aim 4</strong>. To qualitatively determine why young women in Kenya who are at risk for HIV acquisition may choose not to enroll in a PrEP study or initiate PrEP as it relates to views on PrEP and the impact of technology on study involvement. We will interview up to 60 women who met eligibility criteria at screening but do not return for enrollment. We will also conduct at least 10 and up to 12 focus groups among five key populations across the two sites. These focus groups will include: key community leaders, male parents, female parents, young women (ages 18-24 who are not participating in the larger study), and young men (ages 18-24) from the community, assuming one focus group with each population at each site. We are allowing for one additional focus group per site in case of technical difficulties with the digital recorders or other data collection difficulties. Inquiry will be guided by domains from a prior conceptual model we have developed focused on understanding decision-making related to uptake of HIV treatment for prevention, as well as prior research on PrEP uptake and adherence. We will use an iterative approach over the course of data collection.</p>\n
      • principal_inclusion_criteria<p style=\"margin-left:31.7pt;\">\n ·   Female</p>\n<p style=\"margin-left:31.7pt;\">\n ·   HIV-uninfected (as determined by Kenya national testing algorithms)</p>\n<p style=\"margin-left:31.7pt;\">\n ·   Age 18-24 years</p>\n<p style=\"margin-left:31.5pt;\">\n ·   Wanting to start PrEP with an initial recommendation of 6 months of use</p>\n<p style=\"margin-left:31.5pt;\">\n ·   Clinically safe to receive PrEP, in accordance with CDC guidelines:</p>\n<ul>\n <li style=\"margin-left: 31.5pt;\">\n  Creatinine clearance >60 mL/min</li>\n <li style=\"margin-left: 31.5pt;\">\n   Not infected with hepatitis B</li>\n <li style=\"margin-left: 31.5pt;\">\n   No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study</li>\n</ul>\n<p style=\"margin-left:1.0in;\">\n ·   Sexually active (defined as vaginal or anal sex) within the last 3 months</p>\n<p style=\"margin-left:1.0in;\">\n ·   At high risk for HIV infection based on a score of <u>></u>5 or being in an HIV serodiscordant relationship</p>\n<p style=\"margin-left:31.5pt;\">\n ·   Not pregnant</p>\n<p style=\"margin-left:1.0in;\">\n ·   Owns a personal cell phone (not shared) compatible with the technology used in the study and the ability to charge it</p>\n<p style=\"margin-left:1.0in;\">\n ·   Intending to stay in the area for at least the next year</p>\n
      • principal_exclusion_criteria<p style=\"margin-left: 85.5pt;\">\n Unable to provide consent</p>\n<p style=\"margin-left: 85.5pt;\">\n Breast-feeding (Truvada is not currently approved for use during breast-feeding)</p>\n<p style=\"margin-left: 85.5pt;\">\n Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.</p>\n
      • primary_end_points<p>\n Determining adherence to PrEP using Wisepill monitoring device and SMS reminders.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Partners in Health & Research Development Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists and laboratory technologists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Njambi Njuguna  MBChB, MSc, MPH</p>\n
      • other_details_explanation<p>\n In resource-limited settings, cell phones are common and have great potential for adherence intervention when coupled to real-time adherence monitoring. In Kenya, ~30 million people (70% of the population) own cell phones, and mobile technology for health (mHealth) is rapidly developing. Two landmark randomized controlled trials of SMS reminders in Kenya showed significant increases in ART adherence and one showed an increase in viral suppression. Studies assessing real-time adherence interventions are needed for PrEP. </p>\n<p>\n The next generation Wisepill technology offers significant innovations compared with the first generation and has the potential for ready implementation in resource-limited settings, for both research and clinical use.</p>\n<p>\n Wisepill (Figure 1) is a promising emerging technology poised for high impact in understanding adherence through real-time day-to-day measurements of pill taking behavior. A beta-development form of Wisepill has been available for several years; initial limitations included unreliable data transmission, limited battery life, and a challenging user interface in diverse settings (personal communication from Dr. Rivet Amico and Dr. Mirjam Kempf-Collette). Through our prior experience with this device, we are well positioned to test the newly refined next generation technology such that it is “plug and play” and ready for widespread use in research and potentially clinical care.</p>\n<p>\n In the FEM-PrEP and VOICE trials (which involved at-risk women in Kenya, South Africa, Tanzania, Uganda, and Zimbabwe), <30% of participants had objective evidence of PrEP adherence, and no efficacy of PrEP against HIV found as a result. Those data have made some question whether PrEP works for women.  However, in the Partners PrEP (KNH/UoN ERC ref. # P286/05/2012) and TDF2 trials (which involved serodiscordant couples in Kenya and Uganda and heterosexual men and women in Botswana, respectively), women did adhere well to PrEP, and PrEP prevented HIV in subgroups of young, high-risk women, proving that PrEP is efficacious for women when taken. Work done after the VOICE trial suggests that multiple factors contributed to low adherence in that study, including complex perceptions of self-efficacy against HIV risk, HIV and HIV prevention stigma, and components of the clinical trial itself (e.g., blinding, uncertainty about efficacy). </p>\n
      • other_details_regulatory_notapproved<p>\n University of Washington IRB - May 2016</p>\n<p>\n Massachusetts General Hospital (MGH) - May 2016</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (KEMRI) ERC - Approved two sites (Thika & Kisumu)</p>\n<p>\n                                                                                          Approved on May4, 2016 (Thika)</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration4 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
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      • design_controlled_placebo
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      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
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      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site175
      • total_participants_worldwide350
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJessica
      • investigator1_middle_name
      • investigator1_family_nameHaberer
      • investigator1_qualificationMD, MS
      • investigator1_professional_addressMassachusetts General Hospital/Harvard Medical School, Boston USA
      • investigator1_telephone+1 617 724 0351
      • investigator1_emailJHABERER@mgh.harvard.edu
      • organisations_transferred_Yes
      • number_participants350
      • notification
      • approval_date07-09-2016
      • submitted1
      • deleted0
      • deleted_date(null)
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      • date_submitted07-02-2020
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      • balance_site(null)
      • final_date(null)
      • modified2025-03-05 12:59:48
      • created2016-05-11 10:11:00
      • total_sites(null)
      • ecitizen_invoice(null)
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        • id328
        • application_id496
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2016-05-11 11:05:36
        • modified2020-02-07 17:01:35
    • SiteDetail(array)
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        • id391
        • application_id496
        • county_id22
        • site_nameThika Partners Study Clinic (Partners in Health Research and Development)
        • physical_addressOAU Road, Near Thika Nursing Home, Thika Section 9
        • contact_detailsP.O Box 19865-00202
        • contact_personDr. Kenneth Ngure
        • site_capacity(null)
        • misc(null)
        • created2016-05-11 11:05:36
        • modified2020-02-07 17:01:35
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
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        • id392
        • application_id496
        • county_id42
        • site_namePartners in Prevention, Kisumu Site
        • physical_addressAgoi Street
        • contact_detailsP.O Box 614-40100
        • contact_personJosephine B. Odoyo
        • site_capacity(null)
        • misc(null)
        • created2016-05-11 13:20:12
        • modified2020-02-07 17:01:35
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          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • id260
        • application_id496
        • sponsorMassachusetts General Hospital/Harvard Medical School & University of Washington
        • sponsor_typeResearch Institution
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067-22561
        • fax_numbern/a
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2016-05-11 11:05:36
        • modified2020-02-07 17:01:35
  • 1(array)
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      • trial_status_id4
      • abstract_of_study<p style=\"margin: 0px 0px 10px 5pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by the novel severe acute</p>\n<p style=\"margin: 0px 0px 10px 5.05pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n respiratory syndrome coronavirus 2 (SARS-CoV-2). During the current SARS-CoV-2 outbreak, the incidence of known cases has rapidly increased such that, on 30 June  2021, there were 182,629,207 confirmed cases of COVID-19, globally including 3,954,936 deaths, and in Kenya, 183,608 confirmed cases including  3,621 deaths as reported by World Health Organization (WHO). While most cases are mild or asymptomatic, progressive disease can result in hospitalization, requirement for mechanical ventilation, and substantial morbidity and mortality. SARS-CoV-2 is estimated to be about 10 times more deadly than seasonal influenza virus. Risk factors for an unfavorable course include advancing age, obesity, and comorbidities such as diabetes mellitus and hypertension. Weeks and months after the onset of acute COVID-19 some infected patients still continue to suffer from symptoms also called Long-COVID-19 or Post-COVID-19 syndrome. This seems to affect patients with mild COVID-19 as well as those with moderate-to-severe disease. The scale of the pandemic makes the prevention of Long-COVID-syndrome an imperative. It has been hypothesized that by managing the infection earlier post viral syndromes (including Long-COVID-syndrome) could be reduced in incidence and severity. Though several vaccines against SARS-CoV-2 have become available for use, and vaccinations have been initiated in many countries for the most vulnerable and the most exposed population, the limited availability of vaccines in many middle- or low-income countries, is anticipated to remain a bottleneck well beyond 2021, and herd immunity is unlikely before 2023. Interventions that can be administered early during the course of infection to prevent disease progression and longer-term complications are urgently needed.</p>\n<p style=\"margin: 0px 0px 10px 5.05pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This is a randomized, double-blind, placebo-controlled, multicenter study of to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon in ambulatory adult patients with symptomatic COVID-19. The study is composed of two Cohorts: A and B. In Cohort A, 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC to confirm that Novaferon is well-tolerated in target population prior to initiating Cohort B. For Cohort A, the primary outcome is the safety and tolerability of Novaferon treatment as assessed by AEs. Preliminary assessments of clinical efficacy will also be performed. Cohort B is the main portion of the study. This cohort  comprises two  treatment groups. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC. For Cohort B, the primary outcome is the rate of clinical deterioration as of Day 28.</p>\n
      • study_title<h3 align=\"center\" style=\"margin: 10px 0px; font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; line-height: 40px; color: rgb(51, 51, 51); text-rendering: optimizelegibility; font-size: 24.5px;\">\n A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon + SOC vs. Placebo + SOC in Hospitalized Adult Patients with Moderate to Severe COVID-19</h3>\n
      • laymans_summary<p style=\"margin: 0px 0px 10px 5pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Coronavirus disease 2019 (COVID-19) is a disease of the airway caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). During the current SARS-CoV-2 outbreak, the incidence of known cases has rapidly increased such that, on 30 June  2021, there were 182,629,207 confirmed cases of COVID-19, globally including 3,954,936 deaths, and in Kenya, 183,608 confirmed cases including  3,621 deaths as reported by World Health Organization (WHO).While most cases are mild or asymptomatic, the disease that has worsened can result in hospitalization, requirement for assisted breathing, and even death. COVID-19 is estimated to be about 10 times more deadly than seasonal flu caused by influenza virus. The risk factors for an unfavorable course include advancing age, obesity, and comorbidities such as diabetes mellitus and hypertension. Weeks and months after the onset of COVID-19 some infected patients still continue to suffer from symptoms also called Long-COVID-19 or Post-COVID-19 syndrome. This seems to affect patients with mild COVID-19 as well as those with moderate-to-severe disease. The scale of the pandemic makes the prevention of Long-COVID-syndrome an imperative. It is thought that by managing the infection earlier, post viral syndromes could be reduced in incidence and severity. Though several vaccines against COVID-19 have become available for use, and vaccinations have been initiated in many countries for the most vulnerable and the most exposed population, the limited availability of vaccines in many middle- or low-income countries, is anticipated to remain a bottleneck well beyond 2021, and herd immunity is unlikely before 2023. Hence the need for drugs that can be used early during the course of infection to prevent disease progression and longer-term complications.</p>\n<p style=\"margin: 0px 0px 10px 5pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This is a multicenter study designed to use Novaferon in treatment of ambulatory adult patients with symptomatic COVID-19. The study aims to analyse the safety and efficacy of the drug, Novaferon, in adult patients with symptomatic COVID-19. The study is composed of two Cohorts: A and B. In Cohort A, 40 patients will receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC to confirm that Novaferon is well-tolerated in a small population prior to Cohort B. For Cohort A, the primary outcome is to see how Novaferon is safe and well-tolerated in patients. Cohort B is the main portion of the study. In this cohort, up to 874 patients will receive either Novaferon or placebo via a commercial nebulizer, plus SOC. For Cohort B, the primary outcome is to analyse the rate of clinical deterioration in patients as of Day 28.</p>\n<p style=\"margin: 0px 0px 10px 5pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  The overall purpose of the study is to establish the safety and efficacy of aerolized Novaferon in moderate to severe and mild to moderate Covid-19. Participants will be followed up for 2 months. </p>\n
      • short_titleThe \"NOVATION-1\" Trial
      • protocol_noECCT/22/03/01
      • version_no3.0
      • date_of_protocol27-04-2021
      • study_drugNovaferon
      • disease_conditionCOVID-19
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantAmina Salim
      • declaration_date104-03-2022
      • declaration_principal_investigatorDr Bernhards Ogutu
      • declaration_date204-03-2022
      • placebo_presentYes
      • study_objectives<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n ·Cohort A:</p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the safety of aerosolized Novaferon in adult hospitalized moderate and severe COVID-19 patients with confirmed SARS-CoV-2 infection.</li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n ·Cohort B:</p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on the rate of clinical deterioration of adult hospitalized moderate and severe COVID-19 patients with confirmed SARS-CoV-2 infection.\n <h2 style=\"margin: 10px 0px; line-height: 40px; text-rendering: optimizelegibility; font-size: 31.5px;\">\n <u>Secondary Objectives</u></h2>\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n <strong>Cohort B Only:</strong></li>\n </ul>\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on the rate of recovery of adult hospitalized moderate and severe COVIF-19 patients with confirmed SARS-CoV-2 infection</li>\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on hospital discharge rate</li>\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on mortality rate</li>\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on duration of hospitalization</li>\n <li style=\"line-height: 20px;\">\n To evaluate the safety of aerosolized Novaferon</li>\n <li style=\"line-height: 20px;\">\n To assess the effect of Novaferon on clinical improvement measures within 28 days of starting treatment</li>\n </ul>\n <h2 style=\"margin: 10px 0px; line-height: 40px; text-rendering: optimizelegibility; font-size: 31.5px;\">\n <u>Exploratory Objectives</u></h2>\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n <strong>Cohort  A</strong></li>\n </ul>\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n To assess the effect of aerosolized Novaferon on changes in viral load</li>\n <li style=\"line-height: 20px;\">\n To assess the effect of aerosolized Novaferon on i) rate of viral clearance and ii) time to viral clearance</li>\n <li style=\"line-height: 20px;\">\n To assess the effect of aerosolized Novaferon on changes in biomarkers relating to therapy</li>\n <li style=\"line-height: 20px;\">\n To assess the effect of aerosolized Novaferon on the immune system of moderate and severe COVID-19 patients with confirmed SARS-CoV-2 infection</li>\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on hospital discharge rate</li>\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on mortality rate</li>\n <li style=\"line-height: 20px;\">\n To evaluate the effect of aerosolized Novaferon on duration of hospitalization</li>\n <li style=\"line-height: 20px;\">\n To determine and characterize the proportions of SARS-CoV-2 variants</li>\n </ul>\n <p style=\"margin: 0px 0px 10px;\">\n <strong>​</strong></p>\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n <strong>Cohort B</strong></li>\n <li style=\"line-height: 20px;\">\n  To assess the effect of aerosolized Novaferon on changing viral load</li>\n <li style=\"line-height: 20px;\">\n  To assess the effect of aerosolized Novaferon on i) rate of viral clearance and ii) time to viral clearance</li>\n <li style=\"line-height: 20px;\">\n  To assess the effect of aerosolized Novaferon on changes in biomarkers relating to therapy</li>\n <li style=\"line-height: 20px;\">\n  To assess the effect of aerosolized Novaferon on the immune system of moderate and severe COVID-19 patients with confirmed SARS-CoV-2 infection</li>\n <li style=\"line-height: 20px;\">\n To determine and characterize the proportions of SARS-CoV-2 variants</li>\n <li style=\"line-height: 20px;\">\n To correlate clinical outcome measures with SARS-CoV-2 variants </li>\n </ul>\n </li>\n</ul>\n
      • principal_inclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1.  Signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2.  Men and women, ≥18 years of age at time of enrollment.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3.  Laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by PCR, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if RT-PCR test result not available only at the time of screening. Diagnosis to be confirmed by RT-PCR test on Day 1).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4.  Less than or equal to 7 days from COVID-19 symptom onset to starting treatment.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 32.5pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n •  Symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other COVID-19 symptoms as determined by the Investigator.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5.  Hospitalized for no more than 4 days duration, and:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 32.5pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n •  i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (WHO category 4 or 5)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 6. Female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. Male patients must agree to use appropriate contraceptive methods to prevent pregnancy with their partner(s), during the study and up to post 30 days after the last dose of study drug. Female patients must be:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n unable to have children (e.g., post-menopausal*, bilateral tubal ligation,hysterectomy, bilateral oophorectomy) or where the partner is sterile (e.g., vasectomy) OR</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 40.05pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n ●  willing to remain abstinent (not engage in sexual intercourse for the duration of the screening period and throughout the study, and for 30 days after the last dose) OR</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 40.05pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n ● willing to use <u>two</u> approved effective methods of birth control (male partner using condom and female partner using intrauterine device, hormonal or nonhormonal contraceptive, diaphragm plus spermicide, or contraceptive sponge)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n *Post-menopausal is defined as any female who is: (1) older than 55 years with amenorrhea for at least 12 consecutive months; or (2) less than 55 years with amenorrhea for at least two years</p>\n
      • principal_exclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1.  Known hypersensitivity or intolerance to Interferon (IFN) or Novaferon or any excipient(s) of Novaferon, including pre-existing allergy or hypersensitivity to ampicillin.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2.  Currently undergoing invasive mechanical ventilation (including venous ECMO).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3.  Inability to use a nebulizer with a mouthpiece.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4.  ALT/AST > 5 times the Upper Limit of Normal (ULN) or a history of decompensated cirrhosis.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5.  Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/ 1.73m<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">2</span>).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 6.  In the opinion of the Investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 7.  In the opinion of the Investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 8.  Possibility of the patient being discharged from hospital within 24 hours.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 9.  Concurrent participation in other anti-COVID-19 therapeutic or interventional trials. Patients may, at the discretion of the Investigator, concurrently participate in other non-interventional COVID-19 studies.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 10. Current use of other antiviral therapy (e.g., remdesivir, etc.) or other experimental therapy, including anti-inflammatory agents, convalescent plasma, ivermectin or hydroxychloroquine (see Section 9.4.1).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 11. Has received or has a plan to receive within the 28-day treatment period, a SARS- CoV-2 vaccine.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 12. Use of immunomodulatory drugs at, or within 3 months prior to, enrollment; use of chronic oral corticosteroids for a non-COVID-19-related condition at a dose higher than prednisone 20 mg (or equivalent) per day for the preceding 4 weeks.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 13. Other known active infections or other clinical conditions (e.g., chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 14. Patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, and patients with prior transplants.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 18.2pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 15. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n        16. The subject has Acquired Immunodeficiency Syndrome (AIDS) or hepatitis, includinghepatitis virus carriers (HBs-antigen or HCV-antibody-positive). The subject may be included in the study if HCV-antigen or HCV-RNA-negative.</p>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong> Cohort A:</strong></p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px; margin-left: 40.05pt;\">\n Incidence, type, and severity of Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) from time of first dose through Day 56 (i.e., 28 days following Day 28)</li>\n <li style=\"line-height: 20px; margin-left: 40.05pt;\">\n All-cause mortality from first dose through Day 28 following randomization</li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 40.05pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 40.05pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong>Cohort B: </strong></p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px; margin-left: 40.05pt;\">\n Proportion of patients requiring mechanical ventilation or that die (defined as WHO categories 6, 7, or 8) by Day 28 following enrollment</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. CREATES (PI: Dr Bernhards Ogutu):</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The KUTRH is designed for clinical trials and is currently the National COVID-19 referral center with a bed space of 600 and ICU bed of 35 beds and 7 beds in the HDU. Plans are underway to add more beds due to the current surge in patient numbers. We are currently running other COVID-19 treatment trials for mild to moderate disease. It is a referral healthcare facility that has been following government COVID-19 guidelines of care and precautions have been put in place. KUTRH has ample well-equipped clinical laboratories (chemistry, hematology, parasitology, oncology, and pathology), support, radiological services (X-Rays, CT scan, MRI, and ultrasound) and ample clinical observation areas as well as spacious research operations office.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. VIBRI (PI: Dr Lucas Otieno Tina):</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Victoria Biomedical Research Institute (VIBRI) is a non-profit providing pharmaceutical, academic research, and non-profit organizations with a network of clinical sites and expertise focusing on accelerating transformative therapeutics, vaccines, and devices research for major global health diseases in Kenya. VIBRI is located at the Kisumu County Referral Hospital in Kisumu County, western Kenya.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Kisumu County is one of 47 counties in the Republic of Kenya. Its headquarters is <a href=\"https://en.wikipedia.org/wiki/Kisumu\" style=\"color: rgb(51, 51, 51); text-decoration-line: none;\">Kisumu </a>City which is the third largest city in <a href=\"https://en.wikipedia.org/wiki/Kenya\" style=\"color: rgb(51, 51, 51); text-decoration-line: none;\">Kenya</a>. It has a population of 1,155,574 (Kenya National Bureau of Statistics, 2019). The land area of Kisumu County totals 2085.9 km<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">2</span>. The county has a shoreline on <a href=\"https://en.wikipedia.org/wiki/Lake_Victoria\" style=\"color: rgb(51, 51, 51); text-decoration-line: none;\">Lake Victoria</a>, occupying northern, western and a part of the southern shores of the <a href=\"https://en.wikipedia.org/wiki/Winam_Gulf\" style=\"color: rgb(51, 51, 51); text-decoration-line: none;\">Winam Gulf</a>. The city of Kisumu has historically functioned as a major center of Western Kenya commerce. Health in Kisumu County is provided by several institutions that are either private or government funded. There is one teaching and referral hospital, 5 County referral hospitals, 14 sub-county hospitals, 74 dispensaries and 18 health centres in the county.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n VIBRI was established to conduct biomedical research including clinical trials, bioequivalence studies, basic science research studies, epidemiology and population health studies,implementation science studies, build a strong foundation in data science, conduct training and capacity building on clinical research in Kenya. VIBRI has experienced and accomplished clinical research scientists who have designed and conducted GCP compliant phase 1b to phase IV paediatric and adult clinical trials on vaccines and drugs for different indications including malaria, HIV, tuberculosis, diarrhea, sickle cell disease, ebola, pneumonia, polio among many others. The VIBRI Clinical Trials Program will conduct trial activities out of the Kisumu County Referral Hospital and surrounding health facilities. The staff and infrastructure can serve several satellite sites for reaching high-risk populations from Kisumu City.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3. KEMRI Kericho (PI: Dr Isaac Tsikhutsu):</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The site has a long-standing experience in conducting several studies including clinical trials, ranging from therapeutics that included a study of the safety and impact of broadly neutralizing monoclonal antibody therapy with VRC01 on viremia in acute HIV infection, alone or in combination with antiretroviral therapy (ART), vaccines (HIV, Polio, Ebola, Shigella) and cohort studies. The clinical trials range from phase I to IV with age ranges from birth to the elderly, some of which are randomized double blind, placebo controlled and United States Investigational New Drug (IND)/ Food and Drug Administration (FDA)- regulated.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n During this current COVID-19 outbreak, the incidence of known cases in Kericho County as of 16 Apr 2021 were, 2,146 confirmed cases of COVID-19 including 90 deaths, as per Kericho County Situational Report dated 16 Apr 2021.  85% of the cases had mild symptoms and were managed as Home-based Isolation and care. The Kericho CRC is equipped with two emergency rooms (one per floor) with equipment and medications to provide immediate emergency care in the event of emergencies during infusions, of drugs such as anaphylaxis, convulsions, hypotension, and provisions (resuscitation equipment) are in place for immediate resuscitation on site. Additionally, the Kericho site has a standby, fully equipped ambulance for evacuation of participants for more specialized care when necessary. The Kericho County Referral Hospital, which sits in the same compound as the CRC, Siloam hospital, Unilever Tea and Kericho Nursing Hospitals which are within 2 kms radius of the Kericho CRC are COVID-19 treatment centers and the first 2 hospitals have  Intensive Care Units(ICU) which will be utilized should need arise. The study staff (clinicians/nurses) is trained on handling emergencies. In addition there are 2 physicians working in the county who have expertise in management of COVID-19 patients who will be involved in day to day management of patients. Enrollment visit will take place at the Kericho County Hospital, Siloam Hospital, Kericho Nursing Home or Unilever Teal Hospital COVID-19 Isolation wing or in their respective Emergency Units. After discharge participants will be seen at the Kericho CRC either in person or remotely. Remote visits may be done through phone call .</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 7.1pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4. KEMRI Siaya (PI: Dr Simon Kariuki):</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The KEMRI/CGHR clinical research Centre is located inside the Siaya County Referral Hospital in Siaya County, Western Kenya. The hospital serves a predominantly rural population and offers both outpatient and inpatient services with a bed capacity of 420. The hospital has a total staff of 364, with 8 Consultants, 7 Medical Officers, 20 Clinical Officers, 127 Nurses, 4 Pharmacists, 7 Pharmtechs and 20 Laboratory Technologists. It has a well-functioning laboratory for both routine and specialized tests including, biochemistry, Hematology and microbiology. The hospital is one the designated COVID-19 isolation facilities in Siaya County with a bed capacity of 200. KEMRI CGHR clinical research Centre and has a GCP-compliant pharmacy, a laboratory, archiving room, study clinics and a data Centre, Emergency area with BCLS training. </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5. Kenyatta National Hospital (PI Dr John Kinuthia)</p>\n<p>\n This will be a hospital-based study conducted at Kenyatta National Hospital, a level 6 tertiary teaching and referral hospital in Nairobi County. It is the largest public teaching and referral facility in Kenya. The hospital has a 2000 bed capacity, including a 60-bed COVID-19 unit and a six-bed critical care COVID-19 unit. The hospital provides integrated services for all its COVID patients. As a national referral facility, it has a diverse and multidisciplinary team of HCWs including infectious disease specialists, consultant physicians, medical doctors and nursing staff who can review and manage both simple and complicated COVID patients from the greater Nairobi area and throughout the country. Moreover, it also serves as the training hospital for the College of Health Sciences at the University of Nairobi (UoN) and the main campus for the Kenya Medical Training College (KMTC).</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">his phase 3 study will take place in countries in which a high incidence of Covid-19 is projected. Kenya is among those countries. Every effort will be made to identify regions of high SARS-COV-2 activity and populations within these regions with high risk of exposure to the virus will be enrolled. </span></p>\n
      • other_details_regulatory_notapproved<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Peru: Submitted on 15Jun21</li>\n</ul>\n
      • other_details_regulatory_approved<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Canada: Approved on 11Dec20</li>\n <li style=\"line-height: 20px;\">\n Brazil: Approved on 21Jan21</li>\n <li style=\"line-height: 20px;\">\n Argentina: Approved on 24Jun21</li>\n <li style=\"line-height: 20px;\">\n Chile: Approved on 17-Jun-21</li>\n <li style=\"line-height: 20px;\">\n Colombia: Approved on 18Aug21</li>\n <li style=\"line-height: 20px;\">\n Indonesia: Approved on 30Aug21</li>\n <li style=\"line-height: 20px;\">\n South Africa: Approved on 15Apr21</li>\n <li style=\"line-height: 20px;\">\n Turkey: Approved on 16Jul21</li>\n</ul>\n
      • other_details_regulatory_rejected<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">Ukraine</span></p>\n
      • other_details_regulatory_halted<p>\n <span style=\"color: rgb(51, 51, 51); font-family: arial, helvetica, sans-serif;\">The Ukrainian RA demanded that some changes be made to the original protocol before it is resubmitted. More specifically, they wanted information about inhaled toxicology preclinical studies be included in the application.</span></p>\n
      • estimated_durationOne (1) year
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorSaline
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states11
      • number_of_sites5
      • multi_country_listCanada Brazil Argentina Peru Chile Colombia Indonesia South Africa Turkey Ukraine Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_siteThe study is competitive enrolment and there is no minimum or maximum cap per site
      • total_participants_worldwidePart A 40; Part B 874
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyStudy allows for illiterate participants to be enrolled, with witnesses/LAR to sign
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Bernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationPhD; MMed; MBchB
      • investigator1_professional_addressCenter for Research in Therapeutic Sciences(CREATES), P. O. Box, 59857, Nairobi, Kenya
      • investigator1_telephone+254-733-812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participantsKenya will Participate only in Part B and the total number of participants is 60
      • notification
      • approval_date27-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted21-03-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-12-14 17:19:20
      • created2022-02-27 10:44:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id795
        • application_id1122
        • given_nameDr John
        • middle_name
        • family_nameKinuthia
        • qualificationMBChB, MMed, MPH
        • professional_address P.O. Box 20723-00202, Nairobi
        • telephone+254722 799052
        • email_ kinuthia@uw.edu
        • created2022-02-27 11:49:30
        • modified2022-03-21 10:19:20
    • SiteDetail(array)
      • 0(array)
        • id1245
        • application_id1122
        • county_id47
        • site_nameCenter for Research in Therapeutic Sciences(CREATES)
        • physical_addressMadaraka Estate, Ole Sangale Rd, P. O. Box, 59857, Nairobi, Kenya
        • contact_details+254733812613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2022-02-27 11:49:30
        • modified2022-03-21 10:19:20
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1246
        • application_id1122
        • county_id42
        • site_nameVictoria Biomedical Research Institute (VIBRI)
        • physical_addressKisumu County Referral Hospital, P. O. Box 7180, Postal Code 40100
        • contact_details+254714421248
        • contact_personDr Lucas Otieno Tina
        • site_capacity(null)
        • misc(null)
        • created2022-02-27 12:25:10
        • modified2022-03-21 10:19:20
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1247
        • application_id1122
        • county_id35
        • site_nameKEMRI Kericho
        • physical_addressP. O. Box 1357, Postal Code 20200
        • contact_details+254722749789
        • contact_personDr Isaac Tsikhutsu
        • site_capacity(null)
        • misc(null)
        • created2022-02-27 12:25:10
        • modified2022-03-21 10:19:20
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 3(array)
        • id1248
        • application_id1122
        • county_id42
        • site_nameKEMRI Siaya
        • physical_addressSiaya County Referral Hospital, P. O. Box 1578-40100
        • contact_details+254725389246
        • contact_personDr Simon Kariuki
        • site_capacity(null)
        • misc(null)
        • created2022-02-27 12:25:10
        • modified2022-03-21 10:19:20
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 4(array)
        • id1249
        • application_id1122
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_address P.O. Box 20723-00202, Nairobi
        • contact_details+254722 799052
        • contact_personDr John Kinuthia
        • site_capacity(null)
        • misc(null)
        • created2022-02-27 12:25:10
        • modified2022-03-21 10:19:20
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id579
        • application_id1122
        • sponsorSponsor * Genova Inc.
        • sponsor_typeIndustry
        • contact_personDr Qiujin Lyu
        • addressRm1603, 6 Wilmer St., Wai Wah Commercial Ctr, Sai Ying Pun, Hong Kong
        • telephone_number86-136 0108 1204
        • fax_number
        • cell_number86-136 0108 1204
        • email_addressqjlv@genova.cn
        • created2022-02-27 11:49:30
        • modified2022-03-21 10:19:20
  • 2(array)
    • Application(array)
      • id206
      • user_id87
      • trial_status_id1
      • abstract_of_study<p>\n <strong>Study Size </strong>3200 patients</p>\n<p>\n <strong>Study Design </strong>Multicentre, international, blinded, randomized placebo controlled trial of dabigatran and omeprazole (partial factorial design among patients not taking a proton pump inhibitor [PPI]).</p>\n<p>\n <strong>Primary Objectives</strong></p>\n<p>\n To determine the impact of dabigatran versus placebo on the risk of a major vascular complication and omeprazole versus placebo on the risk of a major upper gastrointestinal complication in patients who are followed on average for 1 year.</p>\n<p>\n <strong>Safety Objectives</strong></p>\n<p>\n To determine the impact of dabigatran on the following individual outcomes: life-threatening bleeding, major bleeding, minor bleeding, intracranial bleeding, significant lower gastrointestinal bleeding, non-significant lower gastrointestinal bleeding, or dyspepsia. To determine the impact of omeprazole on the following individual outcomes: Clostridium difficile-associated diarrhea, diarrhea, community-acquired pneumonia, and fractures.</p>\n<p>\n <strong>Inclusion Criteria</strong></p>\n<p>\n Patients are eligible if they fulfill <strong>all </strong>of the following criteria: 1. undergone noncardiac surgery; 2. ≥45 years of age; 3. have suffered myocardial injury after noncardiac surgery (MINS) based upon fulfilling <strong>one </strong>of the following criterions:</p>\n<p>\n A. elevated troponin or CK-MB measurement with one or more of the following defining features: i. ischemic signs or symptoms; ii. development of pathologic Q waves; iii. electrocardiogram changes indicative of ischemia (i.e., ST segment elevation, ST segment depression, or inversion of T waves); iv. new LBBB, or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging.</p>\n<p>\n B. elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism) to MINS. and 4. provide written informed consent to participate while still in hospital after their index surgery and within 5 days of suffering their MINS.</p>\n<p>\n <strong>Exclusion Criteria</strong></p>\n<p>\n Patients are excluded if they fulfill any of the following criteria: 1. hypersensitivity or known allergy to dabigatran; 2. history of intracranial, intraocular, or spinal bleeding; 3. Hemorrhagic disorder or bleeding diathesis; 4. condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart valve, VTE, atrial fibrillation); 5. currently using or plan rifampicin, ketoconazole, or dronedarone; 6. women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study; 7. patient is considered unreliable for study follow-up or study drug compliance; OR 8. previously enrolled in MANAGE. We will also exclude patients in whom any of the following criteria persist beyond 5 days of their suffering MINS: 1. the attending surgeon believes it is not safe to initiate therapeutic dose anticoagulation therapy; 2. the attending physician believes ASA, intermittent pneumatic compression, and/or elastic stockings are not sufficient for VTE prophylaxis and that the patient requires a prophylactic-dose anticoagulant; 3. the patient has an indwelling epidural or spinal catheter that cannot be removed; 4. estimated glomerular filtration rate <35 ml/min, OR 5. it is expected that the patient will undergo cardiac catheterization for MINS .</p>\n<p>\n <strong>Exclusion criteria specific to patients in the omeprazole factorial component:</strong></p>\n<p>\n 1. hypersensitivity or known allergy to omeprazole; 2. requirement for a PPI, an H2-receptor antagonist, sucralfate, or misoprostol; 3. esophageal or gastric variceal disease; OR 4. Patient declines participation in omeprazole arm.</p>\n<p>\n <strong>Treatment Regimen</strong></p>\n<p>\n Dabigatran 110mg (BID) or placebo and omeprazole 20 mg (once daily) or placebo for participants eligible for the PPI factorial component.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • study_title<h3 align=\"center\" style=\"color:blue;\">\n <span style=\"font-size:22px;\"><span style=\"font-family: times new roman,times,serif;\"><strong>M</strong><strong>anagement of myocardial injury After NoncArdiac surgGEry (MANAGE) Trial</strong></span></span></h3>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/08/06
      • version_no4.0
      • date_of_protocol30-11-2012
      • study_drugOmeprazole and Dabigatran
      • disease_conditionMyocardial Injury after Non Cardiac Surgery
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskenneth.juma@aku.edu
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKenneth Juma
      • declaration_date112-08-2013
      • declaration_principal_investigatorProf. Gerald Yonga
      • declaration_date212-08-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Patients are eligible if they fulfill all of the following criteria: 1. undergone noncardiac surgery; 2. ≥45 years of age; 3. have suffered myocardial injury after noncardiac surgery (MINS) based upon fulfilling one of the following criterions: A. elevated troponin or CK-MB measurement with one or more of the following defining features: i. ischemic signs or symptoms; ii. development of pathologic Q waves; iii. electrocardiogram changes indicative of ischemia (i.e., ST segment elevation, ST segment depression, or inversion of T waves); iv. new LBBB, or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging. B. elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism) to MINS. and 4. provide written informed consent to participate while still in hospital after their index surgery and within 5 days of suffering their MINS.</p>\n
      • principal_exclusion_criteria<p>\n Patients are excluded if they fulfill any of the following criteria: 1. hypersensitivity or known allergy to dabigatran; 2. history of intracranial, intraocular, or spinal bleeding; 3. hemorrhagic disorder or bleeding diathesis; 4. condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart valve, VTE, atrial fibrillation); 5. currently using or plan rifampicin, ketoconazole, or dronedarone; 6. women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study; 7. patient is considered unreliable for study follow-up or study drug compliance; OR 8. previously enrolled in MANAGE. We will also exclude patients in whom any of the following criteria persist beyond 5 days of their suffering MINS: 1. the attending surgeon believes it is not safe to initiate therapeutic dose anticoagulation therapy; 2. the attending physician believes ASA, intermittent pneumatic compression, and/or elastic stockings are not sufficient for VTE prophylaxis and that the patient requires a prophylactic-dose anticoagulant; 3. the patient has an indwelling<br />\n epidural or spinal catheter that cannot be removed; 4. estimated glomerular filtration rate <35 ml/min, OR 5. it is expected that the patient will undergo cardiac catheterization for MINS .</p>\n<p>\n Exclusion criteria specific to patients in the omeprazole factorial component:<br />\n 1. hypersensitivity or known allergy to omeprazole; 2. requirement for a PPI, an H2-receptor antagonist, sucralfate, or misoprostol; 3. esophageal or gastric variceal disease; OR 4. patient declines participation in omeprazole arm.</p>\n
      • primary_end_points<p>\n To determine the impact of dabigatran versus placebo on the risk of a major vascular complication and omeprazole versus placebo on the risk of a major upper gastrointestinal complication in patients who are followed on average for 1 year.</p>\n<p>\n To determine the impact of dabigatran on the following individual outcomes: life-threatening bleeding, major bleeding, minor bleeding, intracranial bleeding, significant lower gastrointestinal bleeding, non-significant lower gastrointestinal bleeding, or dyspepsia. To determine the impact of omeprazole on the following individual outcomes: Clostridium difficile-associated diarrhea, diarrhea, community-acquired pneumonia, and fractures.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 3 Staff Members</p>\n<p>\n 1. Dr. Gerald Yonga - Cardiologist and Associate professor of Medicine. Principal Investigator</p>\n<p>\n 2. Dr. Mzee Ngunga - Interventional Cardiologist, Faculty and Consultant. Co Principal Investigator</p>\n<p>\n 3. Mr Kenneth Juma - BSc. Microbiology and Biotechnology (UoN). Research Assistant and Trial Coordinator</p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Not Applicable</p>\n
      • other_details_regulatory_approved<p>\n 1. Aga Khan University Ethical Approval Board</p>\n<p>\n 2. Canada Research Ethics Board</p>\n<p>\n 3. Aga Khan Scientific Review Board</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2 YEARS
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAga Khan University Hospital, Nairobi
      • single_site_physical_addressOff Limuru Rd, 3rd parklands Ave, Aga Khan University Hospital, Department of Medicine, Cardiac Clinic ; 1st Floor Doctors Plaza,
      • single_site_contact_personProf. Gerald Yonga
      • single_site_telephone+254733655551
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states29
      • number_of_sites
      • multi_country_listArgentina, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, France, Germany, Greece, Hong Kong, India, Israel, Italy, Kenya, Netherlands, Nigeria, Peru, Philippines, Poland, Portugal, Russia, South Africa, Spain, Switzerland, Uganda, UK, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_site40
      • total_participants_worldwide3200
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameGERALD
      • investigator1_middle_name
      • investigator1_family_nameYONGA
      • investigator1_qualificationMBChB, MMED, FRCP, FACC, FASC
      • investigator1_professional_addressChair, Department of Medicine, Aga Khan University Hospital, Nairobi, ETB - 6th Floor, P.O. Box 30270-00100, NRB
      • investigator1_telephone+254 020 366 2117/2100/2110
      • investigator1_emailgerald.yonga@aku.edu
      • organisations_transferred_Yes
      • number_participants40
      • notification<p>\n The above attached is a Research checklist form containing a step by step approval process for all the Departments prior to institutional approval and signing of agreement. It ensures that all aspects of preparations and approvals are obtained and in order.</p>\n
      • approval_date30-11-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-08-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2014-11-29 10:22:03
      • created2013-08-12 16:12:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id137
        • application_id206
        • given_nameGERALD
        • middle_nameOCHIENG\'
        • family_nameYONGA
        • qualificationMBChB, MMED, FRCP, FACC, FASC
        • professional_addressChair, Department of Medicine, Aga Khan University Hospital, Nairobi, ETB - 6th Floor, P.O. Box 30270-00100, NRB
        • telephone+254 020 366 2117/2100
        • emailgerald.yonga@aku.edu
        • created2013-08-12 16:22:53
        • modified2013-08-28 18:29:28
      • 1(array)
        • id138
        • application_id206
        • given_nameLEONARD
        • middle_nameMZEE
        • family_nameNGUNGA
        • qualificationMBChB, MMED, Cardiol Fellowship
        • professional_addressFaculty and Consultant, Department of Medicine, Aga Khan University Hospital, Nairobi, ETB - 6th Floor, P.O. Box 30270-00100, NRB
        • telephone+254 020 366 2795/2110
        • emailmzee.ngunga@aku.edu
        • created2013-08-12 16:23:54
        • modified2013-08-28 18:29:28
    • SiteDetail(array)
      • 0(array)
        • id169
        • application_id206
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-08-12 16:22:53
        • modified2013-08-28 18:29:28
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id110
        • application_id206
        • sponsorMANAGE Project Office
        • sponsor_type(null)
        • contact_personSuzan O\'Donnell,
        • addressPOPULATION HEALTH RESEARCH INSTITUTE, Hamilton General Hospital Campus, DBCVSRI 237 Barton Street East, Hamilton, Ontario, Canada L8L 2X2
        • telephone_numberExt. 40508
        • fax_number905-297-3779
        • cell_number905-527-4322
        • email_addressSuzan.ODonnell@phri.ca
        • created2013-08-12 16:22:53
        • modified2013-08-28 18:29:28
  • 3(array)
    • Application(array)
      • id379
      • user_id72
      • trial_status_id5
      • abstract_of_study<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:599px;\" width=\"599\">\n <tbody>\n <tr>\n <td style=\"width:20%;height:106px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Design:</strong></span></p>\n </td>\n <td style=\"width:80%;height:106px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">This study, which shall be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use.</span></p>\n <p style=\"margin-left:.25in;\">\n <span style=\"font-family:verdana,geneva,sans-serif;\">·         Phase I will explore use of the no-flip technique with historical data from standard Shang Ring circumcisions in Africa used as the comparison group. Men will be randomized to Shang Ring removal at 7 days vs. being followed to observe for spontaneous detachment,</span></p>\n <p style=\"margin-left:.25in;\">\n <span style=\"font-family:verdana,geneva,sans-serif;\">·         Phase II will be a randomized trial comparing use of topical vs. injectable anesthesia.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Population:</strong></span></p>\n </td>\n <td style=\"width:450px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">The study population will include Kenyan men and boys ages 10 years and older seeking circumcision at a study sits. A total of 230 participants will be recruited into Phase I and 345 into Phase II. Because of the possibility that boys and men could have different outcomes, we will recruit participants equally in two age groups in both phases; 10-15 and >15 years old.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:126px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Duration:</strong></span></p>\n </td>\n <td style=\"width:450px;height:126px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Approximately 8 months for completion through follow-up of the two phases of the study (exact timing will depend on recruitment rate). In the first phase, participants shall be followed-up at 7, 14, 21, 28, 35, and 42 days post circumcision, although study participation will end once complete wound healing has been documented. In the second phase, participants shall be followed up at 7 and 42 days post-circumcision. In both phases men will be followed beyond 42 days if necessary to document complete wound healing.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Primary Objectives & </strong></span></p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Endpoints:</strong></span></p>\n </td>\n <td style=\"width:450px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Phase I: Assess safety of the no-flip technique for Shang Ring circumcision by determining the rate of moderate and severe adverse events (AE) following use of the no-flip technique. </span></p>\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Phase II: Assess pain experienced during the Shang Ring circumcision procedure with topical vs. injectable anesthesia. The outcome metric would be maximum pain experienced during the Shang Ring circumcision, assessed using the visual analogue scale (VAS) score, reported immediately after completion of the procedure.</span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:20px;\">\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Sites:</strong></span></p>\n </td>\n <td style=\"width:450px;height:20px;\">\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Homa Bay County Hospital, Homa Bay County, Kenya</span></p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Vipingo Health Center, Kilifi County, Kenya</span></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<h2>\n <span style=\"font-size:12px;\"><span style=\"font-family:verdana,geneva,sans-serif;\">Simplifying the Shang Ring Technique for Circumcision of Men and Boys</span></span></h2>\n
      • laymans_summary(null)
      • short_titleSimplifying ShangRing Circumcision for Men and Boys
      • protocol_noECCT/15/01/03
      • version_no4
      • date_of_protocol09-01-2015
      • study_drugN/A
      • disease_conditionN/A
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameShang Ring Device
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressqawori@engenderhealth.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantQuentin Awori
      • declaration_date127-01-2015
      • declaration_principal_investigatorMark Barone - Principal investigator
      • declaration_date227-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Aged 10 years and older;</li>\n <li>\n Uncircumcised upon clinical examination;</li>\n <li>\n In good general health;</li>\n <li>\n Free of genital ulcerations or other visible signs of STI upon clinical examination;</li>\n <li>\n Participant and parent or legally acceptable representative (LAR) as applicable must be able to understand study procedures and requirements of study participation;</li>\n <li>\n Freely consents to participate in the study and signs a written informed consent form if 18 years of age or greater</li>\n <li>\n Accompanied by the parent/LAR, who freely consents and signs an informed consent form for participation of the child into the study for participants less than 18 years old;</li>\n <li>\n Assent from participant less than 18 years old who understand study procedure;</li>\n <li>\n Participant must agree to return to the study site for the full schedule of follow-up visits after his circumcision (or as appropriate the Parent or LAR must agree to bring the participant);</li>\n <li>\n Participant and parent/LAR as appropriate must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Has a known allergy or sensitivity to lidocaine or other local anesthesia;</li>\n <li>\n Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;</li>\n <li>\n Has known bleeding/clotting disorder (e.g. hemophilia);</li>\n <li>\n Has any congenital genitourinary abnormality;</li>\n <li>\n Has an active genital infection, anatomic abnormality or other condition (e.g. diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or,</li>\n <li>\n Is currently participating in another biomedical research study. </li>\n</ol>\n
      • primary_end_points<p>\n <u><strong>Phase I of study</strong></u></p>\n<p>\n Assess safety of the no-flip technique for Shang Ring circumcision by determining the rate of moderate and severe adverse events (AE) following use of the no-flip technique.  </p>\n<p>\n <strong><u>Phase II of study</u></strong></p>\n<p>\n Assess pain experienced during the Shang Ring circumcision procedure with topical vs. injectable anesthesia. The outcome metric would be maximum pain experienced during the Shang Ring circumcision, assessed using the visual analogue scale (VAS) score, reported immediately after completion of the procedure.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyMedical device in individuals above 10 years of age
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <u><strong>Homa Bay</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <li>\n Hospital surgeon (Homa bayu)\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Dr Raymond Simba (Co investigator)- MMED Surg</li>\n </ul>\n </li>\n <li>\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Jairus Oketch</li>\n <li>\n (Still to be recruited)</li>\n </ul>\n </li>\n <li>\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Dan Ouma </li>\n </ul>\n </li>\n <li>\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Nereah Obura</li>\n </ul>\n </li>\n <li>\n Support staff (1)</li>\n</ul>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Site & Facility building</strong></p>\n<p style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n Homa bay distirct hospital - VMMC Theatre</p>\n<p style=\"margin-top: 0px; margin-right: 0px; margin-bottom: 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n ================================================</p>\n<p style=\"margin-top: 0px; margin-right: 0px; margin-bottom: 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <u><strong>Vipingo</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <li>\n Hospital Clinical Officer in charge\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Judy Kinya (Local PI)</li>\n </ul>\n </li>\n <li>\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n (to be recruited)</li>\n </ul>\n </li>\n <li>\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Millie Oundo </li>\n </ul>\n </li>\n <li>\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n David Mwamkita</li>\n </ul>\n </li>\n <li>\n Support staff (1)</li>\n</ul>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Site & Facility building</strong></p>\n<p style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n Vipingo Health Center - theatre</p>\n
      • other_details_explanation<p>\n Kenya was the first country where research on the Shang ring as a device for VMMC was conducted (2009). Since then alot of advancement into the use of the device has be gained plus inroads with the ministry of health (VMMC) and various stake holders.</p>\n<p>\n As this study is aimed at further improving the use of the device, Kenya is most suited to provide this environment of advanced research of this kind.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Weil Cornell Medical College - 3 Oct 2014</p>\n<p>\n Kenya Medical Research Institute (KEMRI) - 9th Jan 2015</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRemoval of day 7 group (P
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNo preset maximum or minimum numbers per site.
      • total_participants_worldwide575
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameQuentin
      • investigator1_middle_name
      • investigator1_family_nameAwori
      • investigator1_qualificationMBChB
      • investigator1_professional_addressABC Place, 2nd floor Waiyaki Way, Westlands, Nairobi
      • investigator1_telephone+254 722 912 616
      • investigator1_emailQAwori@engenderhealth.org
      • organisations_transferred_Yes
      • number_participantsPhase I - 230\nPhase II - 345
      • notification
      • approval_date15-04-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study is now approved
      • final_report<p>\n <strong>Phase 1: Simplifying the ShangRing Technique for Circumcision in Boys and Men: Use of the No-Flip Technique with Randomization to Removal at 7 Days vs. Spontaneous Detachment</strong></p>\n<p>\n Background</p>\n<p>\n Voluntary medical male circumcision is being rolled out to reduce HIV transmission in Sub-Saharan Africa. We assessed safety of the new no-flip ShangRing circumcision technique in males 10 years and older, and determined the clinical course and safety of spontaneous device detachment.</p>\n<p>\n Setting</p>\n<p>\n Two health facilities in Kenya.</p>\n<p>\n Methods</p>\n<p>\n We conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days post-circumcision vs. spontaneous device detachment. The primary outcome was safety of the no-flip technique based on moderate and severe adverse events (AEs). A main secondary outcome was clinical course and safety of spontaneous detachment.</p>\n<p>\n Results</p>\n<p>\n 230 men and boys were circumcised; 114 randomized to 7 day removal and 116 to spontaneous detachment. All circumcisions were successfully completed. There were 6 (5.3%) AEs in the 7-day group and 2 (1.7%) in the spontaneous group; with no significant differences when either were compared to historical data from Africa (p=.07 and p=.79, respectively). There was  no difference in AE rates (p=.169), visit day declared healed (p=.324) or satisfaction (p=.371) between randomization groups. 84 (72.4%) participants in the spontaneous group wore the ShangRing until it detached. The median days to detachment was 14.0 (IQR: 7-21, min-max: 5-35).</p>\n<p>\n Conclusions</p>\n<p>\n The no-flip technique and spontaneous detachment are safe, effective, and acceptable to males 10 years and older. Phimosis and penile adhesions do not limit successful ShangRing circumcision. A single device usable across ages would simplify services, supply chain management, training, and educational materials, and facilitate circumcision scale-up.</p>\n<p>\n <strong>Phase 2: Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial</strong></p>\n<div>\n Background</div>\n<div>\n The ShangRing is a disposable, collar clamp circumcision device pre-qualified for use</div>\n<div>\n in men and boys 13 years and above. It has been shown to be faster than conventional</div>\n<div>\n circumcision with comparable adverse event (AE) rates and high client satisfaction.</div>\n<div>\n The fear of pain during circumcision is an important barrier to uptake of voluntary</div>\n<div>\n medical male circumcision (VMMC). Use of topical anesthesia thus presents an</div>\n<div>\n opportunity to address this.</div>\n<div>\n  </div>\n<div>\n Objectives</div>\n<div>\n We sought to evaluate the safety, effectiveness and acceptability of the use of topical</div>\n<div>\n anaesthesia with ShangRing circumcision of men and boys 10 years of age and above.</div>\n<div>\n  </div>\n<div>\n Methods</div>\n<div>\n Participants were randomised 2:1 to receive topical or injectable anaesthesia. All</div>\n<div>\n participants underwent no-flip ShangRing circumcision. The primary outcome measure</div>\n<div>\n was pain. Secondary outcomes included ease of use of topical versus injectable</div>\n<div>\n anaesthesia, AEs and participant satisfaction.</div>\n<div>\n  </div>\n<div>\n Results</div>\n<div>\n Compared to the topical group, participants in the injectable group reported</div>\n<div>\n significantly more pain on administration of the anesthesia and at approximately 20</div>\n<div>\n minutes after the procedure. Sufficient anaesthesia with topical cream was not</div>\n<div>\n achieved in 21 (9.3%) cases and supplementary injectable anaesthesia was required.</div>\n<div>\n The AE rate was significantly (p<.01) lower in the topical (0%) vs. the injectable group</div>\n<div>\n (4.2%). The most common was pain during the post-operative period. All AEs were</div>\n<div>\n managed conservatively and resolved without sequeale. 96.7% of participants were</div>\n<div>\n satisfied with the appearance of the healed penis and 100% would recommend the</div>\n<div>\n ShangRing to others. All seven male circumcision providers involved in the study</div>\n<div>\n preferred topical to injectable anaesthesia.</div>\n<div>\n  </div>\n<div>\n Conclusions</div>\n<div>\n Our results demonstrate the safety, improved clinical experience, effectiveness, and</div>\n<div>\n acceptability of the use of topical anaesthesia in ShangRing circumcision using the noflip</div>\n<div>\n technique. Topical anaesthesia is an important alternative and has the potential to</div>\n<div>\n increase demand for VMMC while decreasing the risk of needlestick injuries.</div>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-10-10 18:29:03
      • created2015-01-19 09:07:49
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id257
        • application_id379
        • given_nameMark
        • middle_name
        • family_nameBarone
        • qualificationDVM, MS
        • professional_address440 Ninth Avenue, 12th Floor, New York, New York
        • telephone+1 212 561 8084
        • emailmbarone@engenderhealth.org
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
    • SiteDetail(array)
      • 0(array)
        • id308
        • application_id379
        • county_id43
        • site_nameHoma Bay Level IV hospital
        • physical_addressHoma Bay town,
        • contact_details0723 886 261
        • contact_personDr. Raymond Otieno
        • site_capacity(null)
        • misc(null)
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 1(array)
        • id309
        • application_id379
        • county_id3
        • site_nameVipingo Health Centre
        • physical_addressVipingo
        • contact_details0722 235 433
        • contact_personJudy Kinya
        • site_capacity(null)
        • misc(null)
        • created2015-01-19 11:11:35
        • modified2015-01-27 18:25:09
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
    • Sponsor(array)
      • 0(array)
        • id195
        • application_id379
        • sponsorEngenderHealth
        • sponsor_type(null)
        • contact_personMark Barone
        • address440 Ninth Avenue, New york
        • telephone_number+1 (206) 709-3100
        • fax_number
        • cell_number+1 (206) 709-3100
        • email_addressmbarone@engenderhealth.org
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
      • 1(array)
        • id196
        • application_id379
        • sponsorWeill Cornell Medical College
        • sponsor_type(null)
        • contact_personProf. Phillip Li
        • address1300 York Avenue . New York, NY 10065
        • telephone_number+1 (212) 746-5454
        • fax_number
        • cell_number+1 646 341 0033
        • email_addresspsli@med.cornell.edu
        • created2015-01-19 11:48:26
        • modified2015-01-27 18:25:09
  • 4(array)
    • Application(array)
      • id664
      • user_id427
      • trial_status_id5
      • abstract_of_study<div>\n <p>\n Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS. One promising intervention, enterade® (an amino acid–based oral rehydration solution [AA-ORS]), is a medical food product already sold in the United States. It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function, improve nutrient and electrolyte absorption, and improve barrier integrity. There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage (irradiated gut), and it may provide benefit to pediatric EED patients. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure. We will conduct a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and acceptability/tolerability of the product in the target population (children aged 12–24 months) and their caregivers.</p>\n</div>\n<p>\n  </p>\n
      • study_title<h2 align=\"center\">\n Safety, Acceptability, and Feasibility of enterade® in children at risk for environmental enteric dysfunction in Kakamega County, Kenya</h2>\n
      • laymans_summary<div>\n <p>\n Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS. One promising intervention, enterade® (an amino acid–based oral rehydration solution [AA-ORS]), is a medical food product already sold in the United States. It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function, improve nutrient and electrolyte absorption, and improve barrier integrity. There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage (irradiated gut), and it may provide benefit to pediatric EED patients. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure. We will conduct a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and acceptability/tolerability of the product in the target population (children aged 12–24 months) and their caregivers.</p>\n</div>\n<p>\n  </p>\n
      • short_titleSafety, Acceptability, and Feasibility of enterade® (SAFE)
      • protocol_noECCT/18/06/01
      • version_no1.5
      • date_of_protocol07-05-2018
      • study_drugenterade
      • disease_conditionEnvironmental enteric dysfunction
      • product_type_biologicals0
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameAmino Acid-based Oral Rehydration Solution (AA-ORS)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressMArndt@path.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJames Mukabi
      • declaration_date106-06-2018
      • declaration_principal_investigatorMichael Arndt (co-PI)
      • declaration_date206-06-2018
      • placebo_presentYes
      • study_objectives<div>\n <p>\n Primary Objective: To determine the safety of AA-ORS among children with mild to moderate stunting, administered as a daily dose over 2 weeks, ad libitum up to 237 ml in 3 hours.</p>\n <p>\n <em>Safety assessment in children will compare adverse event (AE) and serious adverse event (SAE) rates and changes to dietary and digestive habits between children receiving AA-ORS versus an inactive placebo solution containing no amino acids.</em></p>\n <p>\n Primary Objective: To determine the feasibility and well-tolerated dose of AA-ORS among children with mild to moderate growth stunting administered as a daily dose over 2 weeks, ad libitum up to 237 ml in 3 hours.</p>\n <p>\n <em>User preferences among children include average daily volume consumed over days, trends in volume consumed, and factors that influence children’s willingness and ability to ingest the product as intended.</em></p>\n <p>\n Secondary Objective: To determine the perceptions among caregivers on the use and acceptability of this product as a potential intervention for EED.</p>\n <p>\n <em>Acceptability by caregivers includes factors that influence their willingness to have the product used by their children and their perception of their child’s response to its consumption.</em></p>\n <p>\n Exploratory Objective: To determine the impact of AA-ORS on gut dysfunction, metabolism, gut and systemic inflammation, and micronutrient status.</p>\n <p>\n <em>Impact of AA-ORS on gut dysfunction, systemic inflammation, and micronutrient status</em><em> will be assessed by comparing non-invasive biomarker levels in blood samples collected following the intervention. These biomarkers will be assessed in both groups at baseline in order to have setting-specific descriptive data with which to power a future EED efficacy trial.</em></p>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <u>Pediatric and caregiver pairs (must meet inclusion criteria for both categories):</u></p>\n<p>\n Child:</p>\n<ol>\n <li>\n Is between 12 and 24 months of age.</li>\n <li>\n LAZ between –1 and –3 SD.</li>\n <li>\n At least one week post routine immunization or vitamin A supplementation visit at the study site.</li>\n <li>\n Has a parent or legally acceptable representative willing and able to provide informed consent.</li>\n <li>\n No plans for travel outside of the community for the duration of the study.</li>\n</ol>\n<p>\n Caregiver of child:</p>\n<ol>\n <li>\n Is a parent or legally accepted representative of a child eligible for this study.</li>\n <li>\n Is 18 years of age or older.</li>\n <li>\n Has a working mobile phone.</li>\n <li>\n Is willing and able to provide informed consent.</li>\n <li>\n If illiterate—there is at least one literate adult living in the child’s household.</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n <u>Pediatric and caregiver pairs (must meet none of the exclusion criteria for either category):</u></p>\n<p>\n Child:</p>\n<p style=\"margin-left:.25in;\">\n 1.       Has any sign of acute illness, including but not limited to fever, cough, and diarrhea.</p>\n<p style=\"margin-left:.25in;\">\n 2.       Is wasted (weight for length z-score < –2 or mid-upper arm circumference [MUAC] < 12.4 cm) or has pitting edema.</p>\n<p style=\"margin-left:.25in;\">\n 3.       Is exclusively breastfed.</p>\n<p style=\"margin-left:.25in;\">\n 4.       Is seeking medical attention at the health facility other than for routine, preventative care (e.g., immunization visit, vitamin supplementation).</p>\n<p style=\"margin-left:.25in;\">\n 5.       Has suffered within the prior week from illnesses that might impact nutritional status (e.g., severe diarrhea or pneumonia; vomiting; persistent diarrhea; cleft lip or palate; blindness; tuberculosis; jaundice; renal or cardiac disease; cerebral palsy; known metabolic disorders; and chromosomal disorders, including trisomy 21).</p>\n<p style=\"margin-left:.25in;\">\n 6.       Medical history of chronic health condition (i.e., HIV, hepatitis B or C, end stage renal disease, severe liver disease—absence of a diagnosis is sufficient).</p>\n<p style=\"margin-left:.25in;\">\n 7.       Participating in any other clinical trials.</p>\n<p style=\"margin-left:.25in;\">\n 8.       Recent (prior 2 weeks) use of antibiotics or any other medical treatments (including ORT, but not including vaccines or vitamin/mineral supplementation).</p>\n<p style=\"margin-left:.25in;\">\n 9.       Cannot give the necessary biological (blood) sample.</p>\n<p>\n Caregiver:</p>\n<p>\n Reports diarrhea in the household in the prior 7 days.</p>\n
      • primary_end_points<p>\n <strong>Primary:</strong> Adverse events and serious adverse events through 28 days of follow-up, and changes to dietary and digestive habits through day 21 of follow-up.</p>\n<p>\n <strong>Primary:</strong> Average product volume consumed daily through 21 days of follow-up, time trends in average daily volume consumed, and factors that influence children’s willingness and ability to ingest the product as intended.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyThis study will provide critical information about the safety of commercially available AA-ORS in this at-risk pediatric population and qualitative and quantitative information on the user-preferred product volume for this age group, palatability, and ease of administration.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <p>\n Kakamega CGH is a Level 5 Hospital that offers maternal services, comprehensive care center (CCC) services, maternal and child health unit, comprehensive emergency obstetric care, curative in-patient services, curative outpatient services, family planning, growth monitoring and promotion, HIV counselling and testing, rural health training centre / rural health demonstration centre, Tuberculosis services, laboratory services.</p>\n <table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"547\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Consultants </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p>\n 19, two (2) of which are Pediatricians and two (2) are obstetrician/Gynecologists.</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n General Doctors/Registrars</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 43</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Pharmacists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 7</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Pharmaceutical Technologists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 6</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Medical Laboratory Technologists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 25</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Dental Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 4</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Clinical Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 29</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Nutritionists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 3</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Nursing Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 261</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Public Health officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Health Promotion Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Plaster Technologists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 8</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Medical Social Worker </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Health Administrator </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:5px;\">\n <p>\n Orthopedic Technologists </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:5px;\">\n <p align=\"right\">\n 7</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Physiotherapists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n                11</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Occupational Therapists</p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 6</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Dental Technologists/COHO </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 3</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Records Officers </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 11</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Radiographers                </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 11</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Medical Engineers           </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 9</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Secretaries                       </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Clerical Officers               </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 4</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Drivers                              </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 5</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Telephone Operators    </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Artisans                             </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 1</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Mortuary Attendants     </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 6</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Cooks                                </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n ICT                                     </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 2</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Support Staff                  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 13</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n Casuals                            </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 99</p>\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:236px;height:20px;\">\n <p>\n TOTAL  </p>\n </td>\n <td nowrap=\"nowrap\" style=\"width:311px;height:20px;\">\n <p align=\"right\">\n 586</p>\n </td>\n </tr>\n </tbody>\n </table>\n <p>\n  </p>\n <p>\n <strong>Number of Beds:</strong> 449</p>\n <p>\n  </p>\n <p>\n <strong>Number of Cots:</strong> 79</p>\n <p>\n  </p>\n <p>\n Research study staff:</p>\n <p style=\"margin-left:30.5pt;\">\n <strong>Dr. James Mukabi, MD<em>. </em></strong>Principal Investigator.</p>\n <p style=\"margin-left:30.5pt;\">\n <strong>Alfred Ochola, MPH.</strong> Project coordinator.</p>\n <p style=\"margin-left:30.3pt;\">\n <strong>Dorothy Brown, Kenya Registered Nurse. </strong>Study nurse.</p>\n <p style=\"margin-left:30.3pt;\">\n <strong>Dr. Nick </strong><strong>Aduro</strong><strong> Kidaha, MBChB, MMed (Paeds). </strong>Study pediatrician.</p>\n <p style=\"margin-left:30.3pt;\">\n <strong>Research assistant(s), to be determined. </strong></p>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study will be conducted in Kakamega County in Western Kenya. Kakamega county was selected as containing both rural and urban settings and is suitable for this research due to the high prevalence of malnutrition, and PATH Kenya’s established relationships with health facilities in the area. In former Nyanza province, the stunting (LAZ<-2) prevalence in children under 5 years ranges from 2.5% in Migori County to 5.14% in Kisumu County. In neighboring Western province, where Kakamega is located, the prevalence is thought to be much higher. PATH has been involved in the establishment of the APHIA<em>plus </em>program in western Kenya. APHIA<em>plus</em> promotes HIV testing and improved access to ORS for children experiencing diarrhea through ORS corners in several hundred health facilities in the region. Participants will be recruited from Kakamega County General Hospital (CGH). This facility draws from a peri-urban catchment area, has been participating in APHIA<em>plus</em> programming, and has set up an ORS corner for treatment of pediatric diarrhea. Therefore, health care providers in the facility are quite familiar with the use of ORS.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p align=\"left\">\n None.</p>\n
      • other_details_regulatory_approved<p>\n None.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration4 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo solution
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKakamega County General Hospital (CGH)
      • single_site_physical_addressP.O. Box 15-G.P.O.-50100 Kakamega, Kenya
      • single_site_contact_personVictor Zimbulu, Medical Superintendent
      • single_site_telephone0702930346
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site66
      • total_participants_worldwide66
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren between the ages of 12 and 24 months
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJames
      • investigator1_middle_name
      • investigator1_family_nameMukabi
      • investigator1_qualificationMBChB, MPH
      • investigator1_professional_addressPATH Kakamega- Kenafya Building, Okwemba Road next to Kenya Medical Training College Kakamega 50100
      • investigator1_telephone+254722565432
      • investigator1_emailjmukabi@path.org
      • organisations_transferred_Yes
      • number_participants66
      • notification<p>\n Dear PPB --</p>\n<p>\n Attached please find PATH’s request for closure of the Safety, Acceptability, and Feasibility of Enterade® (SAFE) study in Children at Risk for Environmental Enteric Dysfunction in Kakamega County, Kenya.</p>\n<p>\n The request includes the following documents:</p>\n<ul>\n <li>\n Cover letter</li>\n <li>\n SAFE Executive Summary Final Report</li>\n <li>\n DSMB Final Meeting Minutes</li>\n</ul>\n<p>\n  </p>\n<p>\n We will be submitting the Clinical Study Report to PPB no later than the July 31, 2020 (180 days following study closure).</p>\n<p>\n  </p>\n<p>\n Kindly let us know if you need additional information.</p>\n<p>\n  </p>\n<p>\n Thank you for the support during the study.</p>\n<div>\n  </div>\n
      • approval_date02-10-2018
      • submitted1
      • deleted0
      • deleted_date2018-04-09 14:53:11
      • deactivated0
      • date_submitted28-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in lowresource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure.</p>\n<p>\n We conducted a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and caregiver acceptability of enterade®, an amino acid-based oral rehydration solution (AA-ORS), in the target population of children at risk for EED. Children were randomized to to receive AA-ORS or placebo solution (given ad libitum for 3 hours, up to 237 ml) for 14 days, and compare the rate of adverse events (AEs) in the two groups through 21 days of follow up.</p>\n<p>\n enterade® (an amino acid–based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts and a blend of amino acids that drive the uptake of water and electrolytes. The blend of amino acids appears to reduce intestinal damage and promote healing of the intestinal epithelium in irradiated mouse models commonly used to simulate gut damage encountered in inflammatory bowel diseases. This AA-ORS contains water, a proprietary blend of amino acids (L-Valine, L-Aspartic Acid, L-Serine, L-Threonine, and L-Tyrosine), sodium chloride, sodium citrate, potassium chloride, gum acacia, magnesium chloride, calcium chloride, and stevia leaf extract (sweetener).</p>\n<p>\n A total of 12 participants aged 12-24 months with length for age z-score between -1 and -3, from outpatient department at Kakamega County General Hospital in Kakamega, Kenya were enrolled before the study terminated on May 2, 2019. Several rounds of microbial testing on bottles stored at the study site in Kenya and from the manufacturer’s warehouse confirmed that some of the study product bottles were contaminated with potentially pathogenic microorganisms: <em>Burkholderia cepacia, Cryptococcus uniguttulatus,</em> <em>Exophiala dermatitidis, Exophiala heteromorpha</em>, <em>Capronia munkii, Penicillium roqueforti</em>, and <em>Eurotium herbariorum</em> (a.k.a. <em>Aspergillus glaucus</em> OR <em>Eurotium rubrum</em> (a.k.a. <em>A. rubrum</em>).</p>\n<p>\n Following study termination, an additional weekly safety follow-up of all participants that were enrolled in the study for an additional 6 weeks received ethical approvals as a change to research procedures, but not as an amendment to the protocol. In order to inform SAFE study participants about the study product microbial testing findings and proposed safety follow-up, a letter was sent to each enrolled child-caregiver pair. This letter summarized the current study status; known risks of potential exposure to microbial contaminants; what to do in case of any observed adverse event(s), question, or concern; and details of the purposed 6-week safety follow-up. Subsequently, a consent form addendum was signed by caregivers to authorize the additional safety follow-up procedures.</p>\n<p>\n All 12 participants that were enrolled in the study between February 26, 2019 and March 20, 2019 (the date of study suspension) were contacted and consented to the 6-week safety follow-up. The informed consent form allowed for travel reimbursement on an as-needed basis. The additional weekly safety follow-up for all 12 participants that were enrolled in the SAFE study were conducted between November 20, 2019 and January 16, 2020. All research participants completed the procedures done as part of the additional safety follow-up and/or monitoring.</p>\n<p>\n Any adverse events (AEs) that were noticed by participants, however minor, from the time the study was terminated to date were recorded (see Table 1 below). Five out of the 12 participants reported at least one AE following the study. All safety reports of acute illness were reported recovering/resolving or recovered/resolved. Only PT021 experienced two AEs that were ongoing at the end of the study and thus has no end date recorded.</p>\n<p>\n  </p>\n<p>\n Table 1. Details on adverse events reported by participant during additional safety assessment.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:111px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:69px;\">\n <p>\n <strong>Severity</strong></p>\n </td>\n <td style=\"width:66px;\">\n <p>\n <strong>Start date</strong></p>\n </td>\n <td style=\"width:67px;\">\n <p>\n <strong>End date</strong></p>\n </td>\n <td style=\"width:186px;\">\n <p>\n <strong>Medical action</strong></p>\n </td>\n <td style=\"width:79px;\">\n <p>\n <strong>Resolving/ resolved</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT005</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n      Diarrhea</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/17/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/22/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n ORS and amoxicillin</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n      Fever</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/17/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/19/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Artemether lumefantrine and paracetamol</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT006</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Cough</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/21/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/24/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Amoxicillin, panadol, piriton</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Runny nose</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/21/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/25/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n None</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT016</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Cough</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/24/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 11/27/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Septrin, piriton and panadol</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT021    </strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Cough</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/16/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n Ongoing</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Baby on co-trimoxazole; mother on care</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Night sweats</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 11/16/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n Ongoing</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n None</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n <strong>PT049</strong></p>\n </td>\n <td style=\"width:69px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:66px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:67px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:186px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Diarrhea</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Moderate</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 12/11/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 12/14/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n ORS, piriton, and amoxicillin</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Fever</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Moderate</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 12/11/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 12/12/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n Paracetamol</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:111px;\">\n <p>\n       Vomiting</p>\n </td>\n <td style=\"width:69px;\">\n <p>\n Mild</p>\n </td>\n <td style=\"width:66px;\">\n <p>\n 12/11/19</p>\n </td>\n <td style=\"width:67px;\">\n <p>\n 12/12/19</p>\n </td>\n <td style=\"width:186px;\">\n <p>\n None</p>\n </td>\n <td style=\"width:79px;\">\n <p align=\"center\">\n Y</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n The study closeout visit was conducted once the last participant completed study participation in the additional safety follow-up. The three-day closeout visit was conducted between January 28-30, 2020 by the Independent Study Monitor (ISM). The final DSMB meeting to review additional safety assessment findings and study closeout was held on February 11, 2020.</p>\n<p>\n All study product that were shipped from the study site to the manufacturer and Nelson Laboratories for microbial testing have been discarded. The remaining study product at the study site is accounted for and awaiting destruction in the presence of the Kenyan Pharmacy and Poisons Board (PPB) regulatory representative on February 25-26, 2020.</p>\n<p>\n The completion of biomarker testing of blood samples by staff at the Kenya Medical Research Institute (KEMRI) laboratory in Kilifi is underway to measure enteric dysfunction, systemic inflammation, and micronutrient deficiency in this small pediatric sample. These exploratory analyses are on a small sample size that lacks adequate power for statistical comparisons of the EED outcomes (non-invasive biomarkers); however, the expected results from the exploratory biomarker testing could be useful for understanding EED in this locality and special population and informing study design considerations for future research on AA-ORS and similar EED interventions in LRS. The Environmental Enteric Dysfunction Assessment Tool (MEEDAT) kits to complete the exploratory laboratory assays will measure the average plasma/serum concentrations of gut dysfunction, systemic inflammation, and micronutrient biomarkers will be tested on blood samples that were collected at baseline and day 22 of follow-up. All blood samples following completion of the exploratory laboratory assays by KEMRI will be destroyed.</p>\n
      • implication_results(null)
      • quantity_imported1702
      • quantity_dispensed149
      • quantity_destroyed950
      • quantity_exported471
      • balance_site0
      • final_date0000-00-00
      • modified2020-03-28 00:27:53
      • created2018-03-29 00:53:21
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id418
        • application_id664
        • given_nameMichael
        • middle_nameBenjamin
        • family_nameArndt
        • qualificationPhD
        • professional_address2201 Westlake Ave. Suite 200 Seattle, WA 98121 United States
        • telephone206-285-3500
        • emailmarndt@path.org
        • created2018-03-29 00:56:16
        • modified2020-03-28 00:19:43
      • 1(array)
        • id419
        • application_id664
        • given_nameJames
        • middle_name
        • family_nameMukabi
        • qualificationMBChB, MPH
        • professional_addressPATH Kakamega- Kenafya Building, Okwemba Road next to Kenya Medical Training College Kakamega 50100
        • telephone+254722565432
        • emailjmukabi@path.org
        • created2018-04-03 04:43:20
        • modified2020-03-28 00:19:43
    • SiteDetail(array)
      • 0(array)
        • id536
        • application_id664
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-03-29 00:56:16
        • modified2020-03-28 00:19:43
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id334
        • application_id664
        • sponsorPATH
        • sponsor_typeOthers
        • contact_personMichael Arndt
        • address2201 Westlake Ave. Suite 200
        • telephone_number2062853500
        • fax_number
        • cell_number+19254874527
        • email_addressmarndt@path.org
        • created2018-03-29 00:56:16
        • modified2020-03-28 00:19:43
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php