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• applications(array)
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    • Application(array)
      • id299
      • user_id185
      • trial_status_id2
      • abstract_of_study<p>\n Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces men’s risk of heterosexually-acquired HIV-1 infection by about 60%. Early infant male circumcision (EIMC) confers the same benefits of MC in older ages for prevention of HIV and other sexually transmitted infections, and is less expensive and safer. To provide the evidence-based guidance for implementation of EIMC services, we propose an implementation study to address several salient operations-research questions. Members of our team have conducted a pilot study of the promising, but relatively new AccuCirc device for EIMC in Botswana and found it to be very safe. The AccuCirc device has the potential to greatly simplify supply chain management in addition to eliminating the rare but serious potential complications associated with other EIMC devices. Before it can be included in the WHO’s list of prequalified EIMC devices, however, larger field studies must be conducted. Thus, we propose to enroll 600 infants in a safety and feasibility study of the AccuCirc device. Furthermore, it is imperative to identify, understand and overcome barriers to the adoption and integration of EIMC from the perspective of the provider, about which virtually nothing is known. We will explore, through qualitative methods, the perspective of providers with regard to offering and providing EIMC services. Equally important is having a thorough understanding of decision-making among parents with regard to opting for EIMC. We propose to study this through collection of qualitative data among fathers and mothers (some of whom will have opted for EIMC and some of whom will have declined EIMC services). Lastly, we will gather survey data from mothers in the catchment area where we will be offering home-based and facility-based EIMC services. Data from mothers who opted for EIMC will be compared with those from mothers who did not opt for EIMC to identify factors associated with uptake, including if, when, where and by whom EIMC services were offered. Among providers and parents we will specifically explore what role, if any, the EIMC device plays in decision-making. The findings from this study will provide evidence necessary to refine implementation strategies for EIMC into public health and clinical practice settings and to assist the Kenyan Ministry of Health, PEPFAR and other African governments in the scale-up of EIMC service delivery for long-term HIV prevention.</p>\n
      • study_title<p>\n Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/10/01
      • version_no1.1
      • date_of_protocol14-07-2014
      • study_drugNone
      • disease_conditionEarly Infant Male Circumcision as Part of HIV Prevention Efforts
      • 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_nameAccuCirc
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrplank@partners.org
      • applicant_covering_letter1
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      • declaration_applicantRebeca Plank
      • declaration_date120-05-2014
      • declaration_principal_investigatorFredrick Otieno
      • declaration_date220-05-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p style=\"margin-left:2.9pt;\">\n Infants who are eligible for early infant male circumcision (EIMC) and thus for the study must meet the following inclusion criteria:</p>\n<p style=\"margin-left:2.9pt;\">\n Live-born male infants within the study catchment area (two facilities and their surrounding communities, respectively, served by Domiciliary Midwives (DMs))</p>\n<p style=\"margin-left:2.9pt;\">\n Ability to follow up three or four days after the procedure (and for the first 50 infants, ability to follow-up 24 hours, 3 days, 1 week, and 4 weeks after the procedure)</p>\n<p style=\"margin-left:2.9pt;\">\n Provision of written informed consent by at least one parent or guardian</p>\n
      • principal_exclusion_criteria<p style=\"margin-left:6.25pt;\">\n Exclusion criteria will include not meeting all the inclusion criteria listed above and additionally:</p>\n<p style=\"margin-left:.5in;\">\n ·         Neonatal sepsis or signs of potential illness (e.g., hyperthermia or hypothermia)</p>\n<p style=\"margin-left:.5in;\">\n ·         Penile abnormality that might require reconstructive surgery in the future</p>\n<p style=\"margin-left:.5in;\">\n ·         Family history of bleeding disorder</p>\n<p style=\"margin-left:.5in;\">\n ·         Estimated infant gestational age < 37 weeks</p>\n<p style=\"margin-left:.5in;\">\n ·         Infant delivery weight < 2,500 grams</p>\n<p style=\"margin-left:.5in;\">\n ·         Growth less than 5^th percentile for age</p>\n<p>\n                            Infant > 60 days of age</p>\n
      • primary_end_points<p style=\"margin-left:6.25pt;\">\n The primary outcomes of interest are the frequency, severity, management and outcomes of Adverse Events (AEs) among the 600 AccuCirc EIMC procedures. These data will be measured from intra-operative and post-operative forms. Secondary measures of interest include: median surgical time (measured as minutes elapsed between cleaning the penis and applying the bandage); number of post-operative calls from parents to the AE hotline; number of scheduled and unscheduled post-operative visits from parents; parental satisfaction with AccuCirc EIMC services; and comparison of AE rates among facility-based and home-based EIMCs.</p>\n<p style=\"margin-left:6.25pt;\">\n  </p>\n<p style=\"margin-left:6.25pt;\">\n Also, we will use multivariable conditional logistic regression to examine whether EIMC device-related beliefs, preferences, and self-reported importance of EIMC device is associated with uptake of EIMC. All analyses will control for the frequency matching according to time of recruitment (in quarters) as well as other confounding variables. We will also record if mothers are receiving information about EIMC and are being offered EIMC services, and if so when, where and by whom.</p>\n<p style=\"margin-left:6.25pt;\">\n  </p>\n<p style=\"margin-left:6.25pt;\">\n <em>Outcome variable:</em> The primary outcome (dependent variable) is circumcision status of the infant. In the non-circumcising group, we will request permission from the mother for the infant to undergo a brief genital examination to verify his circumcision status.</p>\n<p style=\"margin-left:6.25pt;\">\n  </p>\n<p style=\"margin-left:6.25pt;\">\n <em>Explanatory variables</em>: The primary independent variables of interest are EIMC device-related beliefs, preferences and self-reported importance of EIMC device. Secondary explanatory variables include demographic characteristics and knowledge of and attitudes toward EIMC.</p>\n<p style=\"margin-left:6.25pt;\">\n  </p>\n<p style=\"margin-left:6.25pt;\">\n Furthermore, two sets of qualitative analyses will be done, one with providers and one with parents.</p>\n<p style=\"margin-left:6.25pt;\">\n  </p>\n<p style=\"margin-left:6.25pt;\">\n Among providers we will explore:</p>\n<p style=\"margin-left:.25in;\">\n ·         Which method is preferred to perform EIMC and reasons for the preference</p>\n<p style=\"margin-left:.25in;\">\n ·         Whether preference for device would vary by setting (home- versus facility-based)</p>\n<p style=\"margin-left:.25in;\">\n ·         Perceived ease to learn and use</p>\n<p style=\"margin-left:.25in;\">\n ·         Perceived safety of device</p>\n<p style=\"margin-left:.25in;\">\n ·         Which method is easier to learn</p>\n<p style=\"margin-left:.25in;\">\n ·         Which method is safer</p>\n<p style=\"margin-left:.25in;\">\n ·         Other logistics such as time it takes to do a procedure, managing the supply chain, managing instrument disinfection and medical waste</p>\n<p style=\"margin-left:.25in;\">\n ·         Perceived barriers and incentives to provision of EIMC services</p>\n<p style=\"margin-left:6.25pt;\">\n  </p>\n<p style=\"margin-left:6.25pt;\">\n Among Parents we will explore: knowledge, attitudes and concerns about EIMC in general; familiarity and perception of advantages and disadvantages related to EIMC device, or preferences for certain features of a device; perception about access to services and availability of providers; decision-making process within a couple; and specific probes about concerns about HIV infection, and other health factors.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyProvider and Parental Impressions
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyThis is a clinical study, not a trial. The device has already undergone testing and is approved by the United States Food and Drug Administration. This is a study of the device as it might be used in Nyanza.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p class=\"TableParagraph\" style=\"margin-left:2.9pt\">\n <span style=\"font-size:12.0pt;\nfont-family:\">The principal investigator, Dr. Rebeca Plank, and the team of Kenyan and U.S.-based investigators that have been assembled for this study have been conducting research for male circumcision and HIV prevention since 1997 and have the experience that will ensure that the research will be conducted rigorously, ethically, and in a timely way. Further they have the experience in translating research into practice - that sound research is used to inform and enhance effective practice.  The team has demonstrated its ability to complete significant implementation science and to see that it is applied effectively on a broad scale.<o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin-left:2.9pt\">\n <span style=\"font-size:12.0pt;\nfont-family:\"> </span></p>\n<p class=\"TableParagraph\" style=\"margin-left:2.9pt\">\n <span style=\"font-size:12.0pt;\nfont-family:\">NRHS has been the leading institution in Kenya for research and for scale-up of male circumcision for HIV prevention. NRHS is a non-governmental organization established in 2002 to be the implementing partner with University of Illinois at Chicago, University of Nairobi and University of Manitoba conducting the study of adult male circumcision (AMC) to reduce HIV incidence in 18-24 year-old men in Kisumu. Since December, 2006, when the results of the randomized trial of male circumcision were announced, NRHS has trained over 1900 health providers in AMC, renovated over 65 health facilities, and performed over 250,000 AMCs. Since 2010 NRHS has introduced early infant male circumcision (EIMC) in 12 health facilities in the Nyanza region and has four trainers in EIMC. NRHS has trained 31 health providers - Clinical Officers and nurses - in EIMC using the Mogen clamp. Two of the four master trainers will be working on this project evaluating the AccuCirc device. The training and initial implementation of AccuCirc will take place at the UNIM clinic.<o:p></o:p></span></p>\n<p class=\"TableParagraph\" style=\"margin-left:2.9pt\">\n <span style=\"font-size:12.0pt;\nfont-family:\"> </span></p>\n<p class=\"TableParagraph\" style=\"margin-left:2.9pt\">\n <span style=\"font-size:12.0pt;\nfont-family:\">The UNIM clinic has approximately 6,400 square feet of space, with two surgical theaters, a fully-equipped laboratory, five counseling rooms, three clinical rooms, large reception area, offices, a conference room, a back-up generator, ample storage space and extensive IT capacity with backup servers.  UNIM has a staff of four clinical officers, three counselors and three nurses, with support staff including receptionists, hygiene officers, mobilizers, accountants, procurement officers, stores and drivers. All clinical staff are trained in emergency procedures and are certified to engage in human subject research and are trained in good clinical practice (GCP). An emergency SOP is in place, and a vehicle and driver are available at all times to transport patients to the Jaramogi Oginga Odinga<i> </i>Teaching and Referral Hospital (JOOTRH) in cases of emergency. <o:p></o:p></span></p>\n
      • other_details_explanation<p style=\"margin-left:.5in;\">\n Kenya has been identified as a World Health Organization-Priority country for scale-up of male circumcision services as part of HIV prevention efforts. In the United States of America, the country of residence for Dr. Plank and Dr. Bailey, most infants are circumcised soon after birth.</p>\n
      • other_details_regulatory_notapproved<p>\n a)            Maseno University in Kenya</p>\n<p>\n b)            IRB of Brigham and Women’s Hospital (sponsor and Dr. Plank’s institution),</p>\n<p>\n c)            University of Illinois at Chicago (Dr. Bailey’s institution)</p>\n
      • other_details_regulatory_approved<p>\n All are still pending.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationThe trial is expected to last three years.
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaNyanza Reproductive Health Society
      • single_site_physical_addressP.O. Box 1764, United Mall, Kakamega Road, Kisumu, Kenya
      • single_site_contact_personDr. Fredrick Otieno
      • single_site_telephone0721759867
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteThere will be one site in Kenya, Kisumu: 2,564 (approximately 600 male infants, 1,882 female adults and 82 male adults)
      • total_participants_worldwideThere is only one site, worldwide and that is in Kisumu, Kenya: 2,564 (approximately 600 male infants, 1,882 female adults and 82 male adults).
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyHealthy, full term male infants without genital abnormalities up to 60 days of life. Consent will be sought from a parent or legal guardian
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFredrick
      • investigator1_middle_name
      • investigator1_family_nameOtieno
      • investigator1_qualificationDCMS, MPH
      • investigator1_professional_addressNyanza Reproductive Health Society, P.O. Box 1764, United Mall, Kakamega Road, Kisumu, Kenya
      • investigator1_telephone0721759867
      • investigator1_emailfotieno@nrhskenya.org
      • organisations_transferred_Yes
      • number_participants2,564 (approximately 600 male infants, 1,882 female adults and 82 male adults).
      • notification
      • approval_date15-01-2015
      • submitted1
      • deleted0
      • deleted_date2015-02-24 21:02:55
      • deactivated0
      • date_submitted03-10-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
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      • admin_stopped_reason(null)
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      • balance_site(null)
      • final_date(null)
      • modified2015-02-24 21:03:36
      • created2014-05-21 02:43:29
      • total_sites(null)
      • ecitizen_invoice(null)
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        • id208
        • application_id299
        • given_nameRebeca
        • middle_nameMilanesi
        • family_namePlank
        • qualificationMD, MPH
        • professional_address15 Francis Street, PBB-A-4, Boston, MA 02115 USA
        • telephone+1-617-525-9656
        • emailrplank@partners.org
        • created2014-05-21 02:48:56
        • modified2014-10-03 00:41:25
      • 1(array)
        • id209
        • application_id299
        • given_nameRobert
        • middle_name
        • family_nameBailey
        • qualificationPhD, MPH
        • professional_addressChicago Developmental Center for AIDS Research, University of Illinois at Chicago, Chicago, IL 60612 USA
        • telephone+1-312-355-0440
        • emailrcbailey@uic.edu
        • created2014-05-21 02:49:00
        • modified2014-10-03 00:41:25
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        • id257
        • application_id299
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        • misc(null)
        • created2014-05-21 02:48:56
        • modified2014-10-03 00:41:25
        • County(empty)
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      • 0(array)
        • id167
        • application_id299
        • sponsorBrigham and Women\'s Hospital
        • sponsor_type(null)
        • contact_personDr. Rebeca Plank
        • address15 Francis Street, PBB-A-4, Boston, MA 02115
        • telephone_number+1-617-525-9656
        • fax_number+1-617-732-6829
        • cell_number+1-617-525-9656
        • email_addressrplank@partners.org
        • created2014-05-21 02:48:56
        • modified2014-10-03 00:41:25
      • 1(array)
        • id168
        • application_id299
        • sponsorUnited States National Institutes of Health
        • sponsor_type(null)
        • contact_personNational Institute of Allergy and Infectious Diseases
        • address5601 Fishers Lane, MSC 9806, Bethesda, MD 20892-9806, USA
        • telephone_number+1-301-496-5717
        • fax_number
        • cell_number+1-301-496-5717
        • email_addressniaidnews@niaid.nih.gov
        • created2014-05-21 02:49:00
        • modified2014-10-03 00:41:25
  • 1(array)
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      • id1091
      • user_id702
      • trial_status_id2
      • abstract_of_study<p>\n One of the biggest cancer challenges in low- and middle-income countries (LMICs) is providing rapid, affordable diagnostics that enable patients to obtain locally available treatments most likely to enable survival based on personalized medicine. Delayed cancer diagnosis – delays between incidence of cancer and patients’ ability to access the pathology services that enable oncologists to prescribe treatment – occurs in many LMICs due to bottlenecks in specimen acquisition, complex specimen handling logistics, lack of pathologists per capita, and infrastructure for tertiary laboratories, which is primarily available in major urban areas. Consequently, this results in missed treatment options for many patients and increased mortality rates. For breast cancer, the most common invasive malignancy amongst women, LMICs represented the majority of >2M new cases globally in 2018 and carried a disproportionate burden of breast cancer morbidity and mortality, with 69% of quality years of life lost due to breast cancer occurring in LMICs. As such, it is of critical public health importance to develop new methods to diagnose cancer that overcome these barriers and extend quality years of life for patients<strong>.</strong></p>\n<p>\n <em>This study</em> seeks to <em>enable same-day diagnostic profiling of breast cancer </em>at the point-of-care using a low-cost, automated system. The goal of this study is to build and validate LMIC- ready diagnostic systems for the analysis of breast fine needle aspirate (FNA) samples of palpable mass lesions. FNA samples can be collected by health workers in decentralized clinics, with deeper lesions sampled using handheld ultrasound devices. The cellular specimen are processed with a fast turn-around time of <1 hour from sample to diagnosis. The end-result is an integrated platform with automated analyses that can be used by non-expert healthcare providers to process samples and escalate results to reviewing pathologists. It answers the questions on whether there are malignant cells in an FNA and the receptor status (ER/PR, HER2) of these cells.</p>\n<p>\n To validate the Aikili technology, we intend to evaluate the performance of the updated Aikili system against gold standard workflows at AKU’s accredited Pathology facilities. Using 40 clinical samples collected by Aga Khan University Hospital, Kenya, this study will compare the sensitivity and specificity of the Aikili diagnostic against accepted gold standards. Our goal is to achieve >90% congruency to match the sensitivity and specificity of current workflows. Phase I of the project will be considered successful when we can show that the field-optimized Aikili system accurately and reliably detects breast cancer receptor status in human FNAs compared to accepted gold standards.</p>\n
      • study_title<p>\n Feasibility and accuracy of nanosensor-based breast cancer diagnosis at the point-of-care-AIKILI technology</p>\n<p>\n  </p>\n
      • laymans_summary<p>\n To validate the Aikili technology, we intend to evaluate the performance of the Aikili system against current clinical workflows for breast cancer diagnostic profiling ( immunohistochemistry). Forty (40) clinical samples will be collected by Aga Khan University Hospital, Nairobi.This study will compare the sensitivity and specificity of the Aikili diagnostic against accepted gold standards. Our goal is to achieve >90% congruency to match the sensitivity and specificity of current workflows.</p>\n<p>\n  </p>\n
      • short_titleAIKILI Technology
      • protocol_noECCT/22/01/06
      • version_no2.0
      • date_of_protocol08-11-2020
      • study_drugAikili Technology Medicinal Device
      • disease_conditionBreast Cancer
      • 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_nameAIKILI Technology
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressveronica.ngundo@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_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data1
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      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
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      • applicant_registration_ctr(null)
      • applicant_pan_african1
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      • declaration_applicantShahin Sayed
      • declaration_date128-01-2022
      • declaration_principal_investigatorShahin Sayed
      • declaration_date203-12-2021
      • placebo_presentNo
      • study_objectives<p>\n This study aims to upgrade Aikili technology by developing rugged <em>custom-designed supplies—</em>including a disposable cartridge and pre-packaged reagent kits—and implement <em>deep learning algorithms </em>for automatic analysis so that the device can be used by non-expert health-care workers. It will also validate the upgraded Aikili system in an LMIC by comparing the sensitivity and specificity of the Aikili diagnostic against accepted gold standards with a goal to achieve >90% congruency to match the sensitivity and specificity of current workflows.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Women above 18 years visiting Aga khan UniversityHospital,Nairobi, suspected to have breast cancer and refered for a biopsy who consent to the study.</p>\n
      • principal_exclusion_criteria<p>\n Women above 18 years visiting Aga khan UniversityHospital,Nairobi, suspected to have breast cancer and refered for a biopsy who do not consent to the study.</p>\n
      • primary_end_points<p>\n  1.Upgrading Aikili technology</p>\n<p>\n  2.Validate the upgraded Aikili system </p>\n<p>\n 3. compare the sensitivity and specificity of the Aikili diagnostic against accepted gold standards with a goal to achieve >90% congruency to match the sensitivity and specificity of current workflows.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • 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_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"618\">\n <tbody>\n <tr>\n <td style=\"width:144px;\">\n <p>\n <strong>Staff, Academic qualification&Institution</strong></p>\n </td>\n <td style=\"width:474px;\">\n <p>\n <strong>Experience</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Dr. Shahin Sayed</p>\n <p>\n MMed, Pathology.</p>\n <p>\n  </p>\n <p>\n AKU</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n Dr. Sayed is the chair and an associate Professor, department of Pathology and laboratory Medicine. Her main research interest has been breast cancers in which she has two international grants as PI in collaboration with the University of Alabama, Birmingham and University of Cape Town and Kwa Zulu Natal. She has also collaborated in Lymphoma research with Prof. Lorenzo Leoncini (University of Siena) and Dr. Aliyah Sohani at Mass General Hospital. She has over 20 publications in her areas of research.</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Dr. Rose Ndumia</p>\n <p>\n MD, Radiology</p>\n <p>\n  </p>\n <p>\n AKU</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n Ndumia is an experienced breast cancer radiologist who is experienced in cancer research.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Prof, Mansoor Saleh,</p>\n <p>\n M.D, Hematology-Oncology / Cancer Center</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n Saleh is a Professor of Medicine, Division of Hematology/Oncology, Scientist, Comprehensive Cancer Center, University of Alabama at Birmingham. He is also the founding Chair, Dept. of Hematology-Oncology and founding Director, AKUN Cancer Center and Clinical Research Unit(CRU). He has a vast experience in research and clinical trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Kelley Laura</p>\n <p>\n MPH,</p>\n <p>\n Global health/Business administration,</p>\n <p>\n  </p>\n <p>\n Akili Biosystems</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n As the CEO of Aikili Biosystems, she has worked with a multi-disciplinary team of practicing oncologists, interventionists, physicists with expertise in computer science, and engineers skilled in deploying miniaturized sensing techniques who, together, have created this technology. Local partners such as The Aga Khan University Hospital and Pyramid Pharma support us to tailor our commercialization approach in sub Saharan Africa and Asia: identifying attractive markets and verticals, as well as understanding clinical standards of care and regulatory considerations.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Min Jouha</p>\n <p>\n PhD,</p>\n <p>\n Biomedical engineering,</p>\n <p>\n  </p>\n <p>\n Akili Biosystems</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n A trained biomedical engineer, has a strong passion in identifying critical real world clinical problems and formulating multidisciplinary solutions. His long term research interests involve the development of biomedical technologies for precise non-invasive disease detection, and to ultimately improve the quality of global healthcare. Through his academic training and research experience at MIT, Harvard and Cornell, he has established a sound foundation in scientific and engineering principles and mastered a breadth of skills from the use of computational modeling to guide biomaterials to the nanofabrication via chemical synthesis and ultimately extensive animal studies.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Peter Ogola</p>\n <p>\n BSC, Medical Laboratory Science</p>\n <p>\n AKUHN</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n A trained medical lab scientist with technical expertise in cytology, tissue processing, embedding, staining, museum techniques, coagulation, transfusion, routine hematology, routine microbiology and routine clinical chemistry</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Research Nurse</p>\n <p>\n  </p>\n <p>\n BSC, Nursing</p>\n <p>\n AKUHN</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n Experience is oncology nursing and research</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:144px;\">\n <p>\n Research Coordinator,</p>\n <p>\n M.A,</p>\n <p>\n AKU</p>\n </td>\n <td style=\"width:474px;\">\n <p>\n Experience in Biomedical research coordination .</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n This trial is to be contacted in Kenya.The applicant is the local principal investigator .The trial targets validation in LMICs.</p>\n
      • other_details_regulatory_notapproved<p>\n National Comission of science Technology and Innovation-June 2021</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration8 Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAga Khan University Hospital, Nairobi.
      • single_site_physical_addressP.O Box 30270-00100
      • single_site_contact_personShahin Sayed
      • single_site_telephone+254 733 719 045
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site40
      • total_participants_worldwide40
      • 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_healthyNo
      • subjects_patientsYes
      • 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_nameShahin Sayed
      • investigator1_middle_name
      • investigator1_family_nameSayed
      • investigator1_qualificationMMed
      • investigator1_professional_addressP.oBOX 30270-00100
      • investigator1_telephone+254733719045
      • investigator1_emailshaheen.sayed@aku.edu
      • organisations_transferred_Yes
      • number_participants40
      • notification<p>\n None</p>\n
      • approval_date21-03-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-01-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe queries raised 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)
      • modified2023-06-12 08:33:10
      • created2021-11-30 08:11:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id750
        • application_id1091
        • given_nameLaura Kelley
        • middle_name
        • family_nameKelley
        • qualificationMPH
        • professional_addressAikili Biosystems Inc., Cambridge, MA, United States,02139
        • telephone+1(617) 899-9838
        • emaillkelley@aikilibio.com
        • created2021-11-30 08:59:11
        • modified2022-01-28 21:27:19
    • SiteDetail(array)
      • 0(array)
        • id1191
        • application_id1091
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-11-30 08:59:11
        • modified2022-01-28 21:27:19
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id556
        • application_id1091
        • sponsorLaura Kelley
        • sponsor_typeIndustry
        • contact_personLaura Kelley
        • addressAikili Biosystems Inc., Cambridge, MA, United States,02139
        • telephone_number+1(617) 899-9838
        • fax_number
        • cell_number+1(617) 899-9838
        • email_addresslkelley@aikilibio.com
        • created2021-11-30 08:59:11
        • modified2022-01-28 21:27:19
  • 2(array)
    • Application(array)
      • id513
      • user_id336
      • trial_status_id4
      • abstract_of_study<p>\n The specific aim of the proposed study is to test the safety and feasibility (Phase 1) and preliminary efficacy (Phase 2) of a new low cost device (Odon Device) to deliver the fetus during prolonged second stage of labor. Although the focus of the proposed study is on the Odon Device as an alternative to available management options for complicated second stage of labour, other potential indications to be studied in the future could include use for assistance during normal delivery and prevention of infections acquired during delivery.</p>\n<p>\n This device may be potentially safer and easier to apply than forceps/vacuum extractor for assisted deliveries, and a safe alternative to some Caesarean sections. It has potential for wide application in resource poor settings even by mid-level providers. If proven safe and effective, the Odon Device will be the first innovation in operative vaginal delivery since the independent development of forceps and the vacuum extractor centuries ago. The Odon device could play a major role in improving intrapartum obstetric care in low resource settings by making possible effective management of intrapartum complications in facilities lacking surgical capacity and/or personnel adequately trained in the use of forceps and the vacuum extractor.</p>\n<p>\n Intrapartum complications are responsible for approximately half of all maternal deaths and two million stillbirth and neonatal deaths per year. Prolonged second stage of labor is associated with potentially fatal maternal complications such as hemorrhage and infection and is a major cause of stillbirth and newborn morbidity and mortality. Evidence indicates that the majority of intrapartum deaths in low-resource settings could be prevented through the introduction of innovative strategies that would increase accessibility of obstetric care (e.g., task shifting). Technological developments such as the Odon device that reduce the skill level and equipment required to provide quality obstetric care are clearly needed.      </p>\n<p>\n Currently, the three main options for managing prolonged second stage of labor are Cesarean section, forceps and vacuum extractor. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for cesarean section) and highly trained staff that are often not available in low resource settings. Even when these options are available, their use is associated with increased maternal and perinatal complications. Safe use of forceps requires very high-level training that is seldom available in low-resource settings. Use of the vacuum extractor is limited by the need for fairly complex equipment requiring maintenance, and it is contra-indicated in women who are HIV positive or with unknown HIV status.</p>\n<p>\n The Odon device is a low cost, easy to use technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby.  It may also protect the baby from intrapartum infection. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care in low resource settings. </p>\n<p>\n The Odon Device was invented by Mr Jorge Odon who holds an intellectual property patent. Mr Odon does not have a medical or biological research background and will participate in the proposed study only in relation to issues on device development.</p>\n<p>\n This study has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as one of the Primary Registries in the WHO Registry Network. The registration number of this trial is ACTRN12613000141741.</p>\n<p>\n The Department of Reproductive Health and Research (HRP/RHR) at the World Health Organization (WHO) is the sponsor of the trial and performs overall coordination.</p>\n
      • study_title<p>\n Feasibility, safety and preliminary efficacy study of a new device (Odón  Device) for assisted vaginal delivery</p>\n
      • laymans_summary<p>\n The specific aim of the proposed study is to test the safety and feasibility (Phase 1) and preliminary efficacy (Phase 2) of a new low cost device (Odon Device) to deliver the fetus during prolonged second stage of labor. Although the focus of the proposed study is on the Odon Device as an alternative to available management options for complicated second stage of labour, other potential indications to be studied in the future could include use for assistance during normal delivery and prevention of infections acquired during delivery.</p>\n<p>\n This device may be potentially safer and easier to apply than forceps/vacuum extractor for assisted deliveries, and a safe alternative to some Caesarean sections. It has potential for wide application in resource poor settings even by mid-level providers. If proven safe and effective, the Odon Device will be the first innovation in operative vaginal delivery since the independent development of forceps and the vacuum extractor centuries ago. The Odon device could play a major role in improving intrapartum obstetric care in low resource settings by making possible effective management of intrapartum complications in facilities lacking surgical capacity and/or personnel adequately trained in the use of forceps and the vacuum extractor.</p>\n<p>\n Intrapartum complications are responsible for approximately half of all maternal deaths and two million stillbirth and neonatal deaths per year. Prolonged second stage of labor is associated with potentially fatal maternal complications such as hemorrhage and infection and is a major cause of stillbirth and newborn morbidity and mortality. Evidence indicates that the majority of intrapartum deaths in low-resource settings could be prevented through the introduction of innovative strategies that would increase accessibility of obstetric care (e.g., task shifting). Technological developments such as the Odon device that reduce the skill level and equipment required to provide quality obstetric care are clearly needed.      </p>\n<p>\n Currently, the three main options for managing prolonged second stage of labor are Cesarean section, forceps and vacuum extractor. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for cesarean section) and highly trained staff that are often not available in low resource settings. Even when these options are available, their use is associated with increased maternal and perinatal complications. Safe use of forceps requires very high-level training that is seldom available in low-resource settings. Use of the vacuum extractor is limited by the need for fairly complex equipment requiring maintenance, and it is contra-indicated in women who are HIV positive or with unknown HIV status.</p>\n<p>\n The Odon device is a low cost, easy to use technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby.  It may also protect the baby from intrapartum infection. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care in low resource settings. </p>\n<p>\n The Odon Device was invented by Mr Jorge Odon who holds an intellectual property patent. Mr Odon does not have a medical or biological research background and will participate in the proposed study only in relation to issues on device development.</p>\n<p>\n This study has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as one of the Primary Registries in the WHO Registry Network. The registration number of this trial is ACTRN12613000141741.</p>\n<p>\n The Department of Reproductive Health and Research (HRP/RHR) at the World Health Organization (WHO) is the sponsor of the trial and performs overall coordination.</p>\n
      • short_titleOdón Device for assisted vaginal delivery
      • protocol_noECCT/17/04/01
      • version_noOdon device Protocol Phase I v8 June 2016
      • date_of_protocol01-06-2016
      • study_drugOdon device
      • disease_conditionDelivery process
      • 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_nameOdon device
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresszahida@qureshi.co.ke
      • 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_countries1
      • 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_plan1
      • applicant_contractual_agreement1
      • declaration_applicantZahida Qureshi
      • declaration_date120-02-2017
      • declaration_principal_investigatorZahida Qureshi
      • declaration_date220-02-2017
      • placebo_presentNo
      • study_objectives<div>\n The main objective of the study is to evaluate the safety and feasibility, in terms of ease of application </div>\n<div>\n and successful delivery, of the BD Odonâ„¢ Device in assisting vaginal delivery in singleton term </div>\n<div>\n pregnancies during the second stage of labour.</div>\n<div>\n  </div>\n
      • principal_inclusion_criteria<div>\n Written informed consent obtained preferably during an antenatal care visit, and always before the initiation of labour. In centres where regular attendance of antenatal care visits might be limited or where no on-site visits are proposed, it is planned that women could be ask to consent during early labour (less than 4 cm dilatation) if not too distressed),</div>\n<div>\n 2. Woman attended at least one antenatal visit at 36 weeks of gestation or more,</div>\n<div>\n 3. Woman is able to read and fully understand the consent information,</div>\n<div>\n 4. Age ≥ 18 and less or equal to 35 years of age,</div>\n<div>\n 5. Singleton pregnancy,</div>\n<div>\n 6. Gestational age equal to or more than 37+0 weeks by best estimate according to local protocols,</div>\n<div>\n 7. Live fetus assessed by methods used according to local protocols,</div>\n<div>\n 8. Fully dilated cervix,</div>\n<div>\n 9. Ruptured membranes (spontaneous or artificial),</div>\n<div>\n 10. Any anterior occiput presentation,</div>\n<div>\n 11. Station level equivalent to 2 cm or more below the spines (e.g. station +2 or lower), or equivalent grading used in study sites,</div>\n<div>\n 12. Fetal heart rate pattern recorded by continuous fetal electronic monitoring meeting the following criteria:</div>\n<div>\n a. Stable baseline rate between 110 and 160 beats/min,</div>\n<div>\n b. normal short and long term variability,</div>\n<div>\n c. absence of late decelerations,</div>\n<div>\n 13. Slightly prolonged second stage of labour, defined as women who have been pushing for at least 30 minutes if nulliparous and 15 minutes if multiparous.</div>\n
      • principal_exclusion_criteria<div>\n Suspected or confirmed maternal infection: Suspected infection will be diagnosed if any of the following are present:</div>\n<div>\n i. Fever ≥ 38 ºC,</div>\n<div>\n ii. Foul smelling amniotic fluid.</div>\n<div>\n 2. More than 24 hours rupture of membranes at the time of delivery or timing of rupture of membranes unknown,</div>\n<div>\n 3. Meconium-stained amniotic fluid,</div>\n<div>\n 4. History of coagulation disorder,</div>\n<div>\n 5. Previous uterine surgery,Intrapartum haemorrhage,</div>\n<div>\n 7. Absolute cephalopelvic disproportion,</div>\n<div>\n 8. Known recto-vaginal-urethral Streptoccocus B Haemolyticcus colonization,</div>\n<div>\n 9. Known HIV positive women,</div>\n<div>\n 10. A history of allergy or previous adverse reaction to latex</div>\n<div>\n 11. Any other condition or circumstance that, in investigator’s opinion, would compromise the safety of the mother or the fetus.</div>\n
      • primary_end_points<p>\n Failure rate of device application</p>\n<div>\n delivery with forceps or vacuum extraction</div>\n<div>\n ï‚· Caesarean section</div>\n<div>\n ï‚· Episiotomy</div>\n<div>\n ï‚· Lacerations of the low genital tract (vulvar, vaginal)</div>\n<div>\n ï‚· Perineal lacerations</div>\n<div>\n ï‚· Cervical laceration</div>\n<div>\n ï‚· Uterine rupture</div>\n<div>\n ï‚· Pelvic haematoma</div>\n<div>\n ï‚· Perineal or vaginal haematoma</div>\n<div>\n ï‚· Postpartum haemorrhage as routinely assessed and defined at the study centres</div>\n<div>\n ï‚· Postpartum endometritis or other infection as reported by study centres</div>\n<div>\n ï‚· Blood transfusion</div>\n<div>\n ï‚· Maternal pain during insertion of the device, using a scale</div>\n<div>\n ï‚· Perineal pain after delivery</div>\n<div>\n ï‚· Maternal experience</div>\n<div>\n 3.3.3.2. Infant outcomes</div>\n<div>\n Incidence of:</div>\n<div>\n ï‚· Abnormal respiratory rate at 2 hours after birth</div>\n<div>\n ï‚· Birth trauma or injuries (skull fracture, caput succedaneum, cephalohaematoma, cutaneous facial lesions and facial palsy, extracranial haemorrhages, subgaleal haemorrhage, subaponeurotic haemorrhage, intracranial injuries)</div>\n<div>\n ï‚· Low Apgar Scores (less than 7 at 1st minute and less than 7 at 5th minute)</div>\n<div>\n ï‚· Any other measure of asphyxia at birth, if collected routinely</div>\n<div>\n ï‚· Admission to Neonatal Intensive Care Unit</div>\n<div>\n ï‚· Length of stay (> 7 days) in neonatal intensive care unit</div>\n<div>\n <div>\n ï‚· Retinal haemorrhage</div>\n <div>\n ï‚· Anaemia</div>\n <div>\n ï‚· Jaundice</div>\n <div>\n ï‚· Infection</div>\n <div>\n ï‚· Phototherapy</div>\n <div>\n ï‚· Fetal or neonatal death</div>\n</div>\n<p>\n  </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_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhased trial in humans
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Staff</p>\n<p>\n Prof Zahida Qureshi MBChB MMed ObGyn- PI</p>\n<p>\n Dr Alfred Osoti MBChB MMed (ObGyn) MPH-CoPI</p>\n<p>\n Midwives (2) to be identfied</p>\n<p>\n Infraestructure</p>\n<p>\n Comprehensive emergency obstetric and newborn care available on-site</p>\n
      • other_details_explanation<p>\n The study wil be implemented in low-middle-income countries</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Kenyatta National Hospital University of Nairobi ERC</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKenyatta National Hospital
      • single_site_physical_addressOff Ngong Road
      • single_site_contact_personZahida Qureshi
      • single_site_telephone00254733605140
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listArgentina, South Africa, kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site20
      • total_participants_worldwide108
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_nameQureshi
      • investigator1_qualificationMBChB MMed
      • investigator1_professional_addressDepartment of Obs and Gyn, University of Nairobi,PO Box 19676 Nairobi Kenya
      • investigator1_telephone00254733605140
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_Yes
      • number_participants20
      • notification
      • approval_date22-06-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted14-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This was a proposal for implementation of the WHO A65711 study in four hospitals in South AfricaThis was a proposal for implementation of the WHO A65711 study in one hospital at Kenyatta Hospital, in Nairobi. No woman was recruited under this study in Kenya.</p>\n<p>\n A prototype of the BD Odon device^TM  (BD, Franklin Lakes, NJ, USA) was used in one case in South Africa in 2017, before the company decided to stop supplying the devices to the WHO study and this trial was consequently terminated.One woman was recruited and application of the device failed.</p>\n<p>\n  </p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-08-14 11:45:02
      • created2016-07-01 14:46:35
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id337
        • application_id513
        • given_nameZahida
        • middle_name
        • family_nameQureshi
        • qualificationMBCHB MMed
        • professional_addressDepartment of Obs and Gyn, University of Nairobi,PO Box 19676 Nairobi Kenya
        • telephone00254733605140
        • emailzahida@qureshi.co.ke
        • created2016-07-06 06:48:19
        • modified2020-08-14 11:45:02
    • SiteDetail(array)
      • 0(array)
        • id399
        • application_id513
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-07-06 06:48:19
        • modified2020-08-14 11:45:02
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id267
        • application_id513
        • sponsorThe World Health Organization
        • sponsor_typeResearch Institution
        • contact_personMercedes Bonet
        • addressThe World Health Organization Headquarters
        • telephone_number004122 791 3347
        • fax_number
        • cell_number004122 791 3347
        • email_addressbonetm@who.int
        • created2016-07-06 06:48:19
        • modified2020-08-14 11:45:02
  • 3(array)
    • Application(array)
      • id573
      • user_id81
      • trial_status_id8
      • abstract_of_study<p>\n Children with complicated severe acute malnutrition (SAM) admitted to hospital in sub-Saharan Africa have a case fatality between 12% and more than 20%. Because children with SAM may not exhibit the usual signs of infection, WHO guidelines recommend routine antibiotics. However, this is based on “low quality evidence”. There is evidence from CGMR-C, Kilifi and from other centres in Africa that bacterial resistance to the currently recommended first-line antibiotics (gentamicin plus ampicillin or penicillin) may be less effective than potential alternatives. Some hospitals in Africa are already increasing use of ceftriaxone as a first-line treatment. However, this is not based on any data that ceftriaxone actually improves outcomes. Of concern is that ceftriaxone use may also lead to increased antimicrobial resistance, including inducing extended spectrum beta-lactamase (ESBL) and other classes of resistance. We are currently undertaking a study to assess the prevalence of carriage of bacteria expressing ESBL (KEMRI/SERU/CGMR-C/023/3161; OxTREC 47-15). A further area where evidence for policy is lacking is the use of metronidazole in severely malnourished children. The WHO guidelines recommend “Metronidazole 7.5 mg/kg every 8 h for 7 days may be given in addition to broad-spectrum antibiotics; however, the efficacy of this treatment has not been established in clinical trials.” Metronidazole is effective against anaerobic bacteria, small bowel bacterial overgrowth, Clostridium difficile colitis and also Giardia, which is common amongst children with SAM. Small cohort studies of metronidazole usage suggest there may be benefits for nutritional recovery in malnourished children. However, metronidazole can cause nausea and anorexia, potentially impairing recovery from malnutrition and may also rarely cause liver and neurological toxicity. This multicentre clinical trial will assess the efficacy of two interventions, ceftriaxone and metronidazole, on mortality and nutritional recovery in sick, severely malnourished children in a 2x2 factorial design. There will also be an analysis of antimicrobial resistance and an economic analysis. To extend our understanding of metronidazole and ceftriaxone pharmacokinetics from protocol KEMRI/SERU/CGMR-C/023/3161; OxTREC 47-15’, additional pharmacokinetic data for the dosing schedule used in the trial will be collected from 120 participants. The trial will be conducted at Kilifi County Hospital, Coast General Hospital, Mbagathi Hospital in Kenya and Mbale Regional Referral Hospital in Uganda. The trial will assess antimicrobial resistance that is carried by children in their intestines and in invasive bacterial isolates. The relative costs of care for SAM for health facilities and for families, including antimicrobial usage will also be assessed. Clear data on the benefits, risks and costs of these antimicrobials will influence policy on case management and antimicrobial stewardship in this vulnerable population.  </p>\n
      • study_title<p>\n First Line Antimicrobials in Children with Complicated Severe Acute Malnutrition</p>\n
      • laymans_summary<h4>\n Lay Title</h4>\n<p>\n A study to compare antibiotics used to treat children with severe acute malnutrition.</p>\n<h4>\n What is the problem?</h4>\n<p>\n Children with severe malnutrition who are admitted sick to hospitals have a high mortality, usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics. However, we are not sure that the current antibiotics are the most effective. It is possible that the antibiotics that are currently used as second-line should be used first. No studies have been carried out to determine if the current antibiotics used for treating malnourished children are the most appropriate. We will therefore carry out this large trial comparing different antibiotics to find out this.</p>\n<h4>\n What questions are we trying to answer?</h4>\n<p>\n We want to find out if a revised antibiotic regime for children with complicated severe acute malnutrition is safe, reduces the risk of death and improves nutritional recovery. We also want to find out how often children carry bacteria that are resistant to antibiotics in their intestines and the effects of different antibiotics on the ability for bacteria to resist antibiotic treatment and the costs to hospitals and to families of treating malnourished (SAM) and without SAM children with the different antibiotics.</p>\n<h4>\n Where is the study taking place, how many people does it involve and how are they selected?</h4>\n<p>\n We will carry out the study in Kilifi County Hospital, Coast General Hospital in Mombasa, and Mbagathi hospital in Nairobi, Kenya and Mbale Regional Referral Hospital, Uganda. We will enrol 2,000 children with severe malnutrition admitted to hospital. We will ask parents and guardians of all children between the ages of 2 months to 13 years who are admitted to hospital with severe malnutrition and would normally be treated with antibiotics according to current guideline to participate and enrol an equal number of children at each site who are admitted without SAM to examine faecal samples for bacteria that may be resistant to antibiotics.</p>\n<h4>\n What does the study involve for those who are in it?</h4>\n<p>\n After informed consent, a study clinician will examine the child and prescribe antibiotics that have been randomly allocated. A small volume of blood and a faecal sample will be taken for this research in addition to the routine tests for care at admission before antibiotic administration, and again at discharge. The children will be reviewed daily by the study team, working together with the hospital staff to provide the best care available in the hospital. Children will be followed up for 90 days from enrolment with 3 scheduled follow up visits involving a health questionnaire, anthropometry and the collection of a faecal sample at two of the visits. The levels of the antibiotics being used will be checked in the blood of 120 participants at Kenyan sites whilst in hospital. Parents and carers of approximately 650 children in both SAM and without SAM across all sites may also be interviewed about any costs they have met as a result of the child needing healthcare. If a child requires readmission to hospital, a small volume of blood will be drawn to try and determine the cause. Results of blood tests will be fed back to the clinical team to assist in care. For non-severely malnourished children, a rectal swab will be taken at admission and discharge, and information collected during admission, but we will do no additional samples or further follow up.</p>\n<h4>\n  </h4>\n<p>\n  </p>\n<p>\n  </p>\n<h4>\n What are the benefits and risks/costs of the study for those involved? </h4>\n<address>\n Training will be enhanced for all paediatric ward staff on treatment of sick and malnourished children and assisting with control of infections within the hospitals. Drawing a blood sample carries the risks of discomfort and damage to the vein or infection; careful procedures including cleaning the skin will help prevent these. Rectal swabs and faeces collection have minimal risk. Travel costs and lost earnings associated with scheduled follow up visits will be reimbursed, based on national guidelines.</address>\n<h4>\n How will the study benefit society? </h4>\n<p>\n Knowing how better to use antibiotics in malnourished children when they are admitted to hospital will help decision-making to improve their health and survival. The findings from this research will directly inform policy and program management decisions related to the care of the sick child.</p>\n<h4>\n When does the study start and finish?</h4>\n<address>\n The study aims to start as soon as scientific and ethical approval is granted, follow up for participants is expected to continue for about 3 years and the overall study for about 5 years.</address>\n<p>\n  </p>\n
      • short_titleFLACSAM
      • protocol_noECCT/17/03/03
      • version_no1.04
      • date_of_protocol20-03-2019
      • study_drugCeftriaxone, Metronidazole, Penicillin, Gentamicin
      • disease_conditionSevere Acute Malnutrition
      • 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_nameCeftriaxone, Metronidazole, Penicillin, Gentamycin, Metronidazole placebo
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.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_countries1
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • 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_applicantNancy Kagwanja
      • declaration_date120-03-2017
      • declaration_principal_investigatorProf. Jay Berkley
      • declaration_date220-03-2017
      • placebo_presentYes
      • study_objectives<h2>\n 1.1Null hypotheses</h2>\n<ul>\n <li>\n Mortality amongst children admitted to hospital with complicated SAM is not altered by administration of intravenous ceftriaxone or metronidazole as first line agents compared to penicillin plus gentamicin.</li>\n</ul>\n<h2>\n Primary objective</h2>\n<p>\n Amongst children with complicated SAM, to establish whether:</p>\n<ul>\n <li>\n Mortality is reduced during 90 days when treated with broader spectrum first-line antibiotics (ceftriaxone or metronidazole), compared to the currently recommended narrower spectrum antibiotics (penicillin and gentamicin).</li>\n</ul>\n<h2>\n Secondary objectives</h2>\n<p style=\"margin-left:36.0pt;\">\n To evaluate in trial participants:</p>\n<ul>\n <li>\n Suspected grade 4 toxicity and serious adverse events</li>\n <li>\n Mortality in hospital and after discharge</li>\n <li>\n Duration of hospitalisation and antimicrobial administration</li>\n <li>\n Frequency and causes of readmission to hospital during follow up</li>\n <li>\n Recovery of nutritional status during follow up</li>\n <li>\n Aetiology of infections occurring during the study and faecal carriage of bacteria expressing Extended Spectrum Beta Lactamase (ESBL), at admission, discharge and follow up</li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<h3>\n ·Inclusion criteria – clinical trial participants (SAM)</h3>\n<ul>\n <li>\n Age 2 months to 13 years inclusive</li>\n <li>\n Severe malnutrition defined as: kwashiorkor; or MUAC <11.5cm in children in children between 6 to 59 months or MUAC <11cm in children aged 2 to 59 months; or weight-for length Z score <-3; or  BMI-for-age Z score <-3 or MUAC <11.5cm in children aged 5 to 13 years.</li>\n <li>\n Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines</li>\n <li>\n Planning to remain within the hospital catchment area and willing to come for specified visits during the 90 day follow up period</li>\n <li>\n Informed consent provided by the parents/guardian</li>\n</ul>\n<h3>\n ·Inclusion criteria - antimicrobial pharmacokinetics (SAM)</h3>\n<ul>\n <li>\n A convenience sample of the children with SAM enrolled in the trial during normal working hours</li>\n</ul>\n<h3>\n ·Inclusion criteria – non-trial participants for faecal carriage of resistance (without SAM)</h3>\n<ul>\n <li>\n Age 2 months to 13 years inclusive</li>\n <li>\n Without SAM (as defined above) and admitted during normal working hours</li>\n <li>\n Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines</li>\n <li>\n Informed consent provided by the parents/guardian</li>\n</ul>\n<p>\n <br />\n  </p>\n
      • principal_exclusion_criteria<h3>\n ·Exclusion criteria – clinical trial participants (SAM)</h3>\n<ul>\n <li>\n Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or metronidazole</li>\n <li>\n A specific and documented clinical indication for another class of antibiotic</li>\n <li>\n Previously enrolled in this study</li>\n</ul>\n<h3>\n ·Exclusion criteria – non-trial participants for faecal carriage of resistance (without SAM)</h3>\n<p>\n Previously enrolled in this study</p>\n
      • primary_end_points<ul>\n <li>\n Mortality -(ceftriaxone), compared to the currently recommended narrower spectrum antibiotics (penicillin and gentamicin).</li>\n <li>\n Mortality-oral metronidazole, compared to placebo.</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • 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_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n <strong>Site</strong></td>\n <td>\n <strong>Name</strong></td>\n <td>\n <strong>Qualification</strong></td>\n <td>\n <strong>Experience</strong></td>\n </tr>\n <tr>\n <td>\n Kilifi</td>\n <td>\n Prof. James Berkley</td>\n <td>\n Professor of Paediatric  Infectious Diseases</td>\n <td>\n Prinicipal Investigator, Paediatric Consultant in infectious diseases</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Dr Neema Mturi</td>\n <td>\n MBChB</td>\n <td>\n Consultant Paediatrician</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Dr Caroline Ogwang</td>\n <td>\n MBChB, MsC Epidemiology</td>\n <td>\n Clinical trials experience, Lead clinician, Care of severely malnourished children,</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Nancy Kagwanja</td>\n <td>\n BScN, MPH</td>\n <td>\n Clinical Trials Coordination, Monitoring, quality assurance</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Sheila Murunga</td>\n <td>\n BSc Computer Science and Statistics</td>\n <td>\n Data management, analysis</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Joseph Waichungo</td>\n <td>\n Bsc Medical Laboratory Sciences, Registered Laboratory Technician</td>\n <td>\n Medical microbiology diagnostics and quality assurances, sampling, Sample processing and sample management,</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Johsntone Thitiri</td>\n <td>\n BScN, MSc Clinical Trials</td>\n <td>\n Clinical Trial Coordination, Monitoring, quality assurance</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Jimmy Shangala</td>\n <td>\n Bsc Pharmacy</td>\n <td>\n Clinical Trials Pharmacy, Vaccine product management, oversight on investigational products at clinical trial sites</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Shalton Mwaringa</td>\n <td>\n HND-Paediatrics, Registered Clinical Officer</td>\n <td>\n Site lead clinician, Clinical trial experience, Care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Rehema Ali</td>\n <td>\n KRCHN, MSc Clinical Trials</td>\n <td>\n <p>\n Study nurse, clinical trial experience,<br />\n Care of severely malnourished children</p>\n </td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Grace Dena</td>\n <td>\n Registered Clinical Officer, MSc Clinical Trials</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Mwanamvua Boga</td>\n <td>\n KRCHN, MSc Clinical Trials</td>\n <td>\n Nurse manager, clinical trials expereince, care of critically ill children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Prof. Kathryn Maitland</td>\n <td>\n Professor of Paediatric Tropical Infectious Diseases</td>\n <td>\n Paediatric Consultant on Infectious Diseases</td>\n </tr>\n <tr>\n <td>\n Coast General Hospital</td>\n <td>\n Dr Victor Bandika</td>\n <td>\n MBChB, MMed Paediatrics</td>\n <td>\n Paediatric consultant</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Laura Mwalekwa</td>\n <td>\n HND-Paediatrics, Registered Clinical Officer</td>\n <td>\n Site Lead clinician, clinical trials experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Fauzat Hamid</td>\n <td>\n Registered Clinical Officer</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n John Paul Odhiambo</td>\n <td>\n Registered Clinical Officer</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Jones Makori</td>\n <td>\n BSc Pharmacy, MSc, Pharmacoepidemiology</td>\n <td>\n Site Pharmacist,</td>\n </tr>\n <tr>\n <td>\n Mbagathi</td>\n <td>\n Dr Christine Manyasi</td>\n <td>\n MBChB, MMed-Paediatrics</td>\n <td>\n Paediatric consultant</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Molline Timbwa</td>\n <td>\n HND-Paediatrics, Registered Clinical Officer,</td>\n <td>\n Site Lead Clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n  </td>\n <td>\n Joshua Wambua</td>\n <td>\n Registered Clinical Officer</td>\n <td>\n Study clinician, clinical trial experience, care of severely malnourished children</td>\n </tr>\n <tr>\n <td>\n Mbale Regional Referral Hospital, Uganda</td>\n <td>\n Dr Peter Olupotolupot</td>\n <td>\n MBChB, MPH, PHD</td>\n <td>\n Local principal investigator, clinical trial experience, care of critically ill children</td>\n </tr>\n <tr>\n <td colspan=\"4\">\n <p>\n Each site will be supported by a clinical team comprising of the hospital's paediatric consultant and study clinicians, a nurisng team and fieldworkers with experience in clinical research and communication with patients and study participants.</p>\n <p>\n Kilifi County Hospital and Mbagathi Hospital are level 4 hospitals with sufficient emergency facilities and infrastructure for patient referral. Kilifi Hospital also has a High Dependency Unit in it's paediatric department. Coast General Hospital is a level 5 hospital with efficient emergency facilities, a paediatric observation ward and facilities to provide acute care. Mbale Hospital is a regional referral hospital. Within it's paeaditric department it also has a High Dependency Unit for patients requiring critical care.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n In Uganda, the protocol was submitted and approved by National Drug Authority (NDA).</p>\n
      • other_details_regulatory_approved<p>\n NDA- In Uganda and UNCST</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationThe trial enrolment and follow up will be conducted during a period of 3 years. A further 2 years will be required for analysis, dissemination and to complete the secondary laboratory analyses.
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyThe trial will investigate two separate antimicrobial interventions in a 2x2 factorial design randomised controlled clinical trial. Two randomisations will be made. The two interventions will be analysed separately.
      • design_controlled_comparatorStandard of Care-(penicil
      • design_controlled_other_medicinalYes
      • 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_states2
      • number_of_sites3
      • multi_country_listKenya\nUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment--Minimum number per site 300, Maximum number per site- 1000
      • total_participants_worldwide2000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • 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 aged between 2 months and 13 years inclusive. They will require their parent(s)/guardian(s) consent to participate in the study.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJames
      • investigator1_middle_name
      • investigator1_family_nameBerkley
      • investigator1_qualificationProfessor of Paediatric Infectious Diseases
      • investigator1_professional_addressKEMRI Wellcome Trust Research Programme, P.O BOX 230-80108 Kilifi
      • investigator1_telephone+254 720867011
      • investigator1_emailJBerkley@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants1300
      • notification<p>\n None</p>\n
      • approval_date21-06-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-03-2020
      • 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)
      • modified2022-10-31 11:27:09
      • created2016-11-29 11:57:26
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id369
        • application_id573
        • given_nameJames
        • middle_name
        • family_nameBerkley
        • qualificationProfessor of Paediatric Infectious Diseases
        • professional_addressKEMRI Wellcome Trust Research Programme, P.O BOX 230-80108 Kilifi
        • telephone+254 720867011
        • emailJBerkley@kemri-wellcome.org
        • created2016-11-29 12:43:14
        • modified2020-03-07 13:40:56
    • SiteDetail(array)
      • 0(array)
        • id452
        • application_id573
        • county_id3
        • site_nameKilifi County Hospital
        • physical_addressBahari off Bofa Road, P.O BOX 9-80108 Kilfi
        • contact_detailsP.O BOX 9-80108 Kilfi
        • contact_personCaroline Ogwang
        • site_capacity(null)
        • misc(null)
        • created2016-11-29 12:43:14
        • modified2020-03-07 13:40:56
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 1(array)
        • id453
        • application_id573
        • county_id1
        • site_nameCoast General Hospital
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        • contact_detailsMombasa, 80100
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        • physical_address Kenyatta N. Hospital Golf Course Estate, Nairobi, Kenya ...
        • contact_details P.O.Box: 20725-00202, Nairobi
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      • id1507
      • user_id73
      • trial_status_id2
      • abstract_of_study<div>\n Background: Local data availability on HPV disease burden, prevalence, vaccination coverage and impact of vaccination has been challenging in Africa due to the absence or lack of cancer registers, vaccination registers, population databases and electronic health information systems. Therefore, generating local data and promoting capacity building at local institutes is critical to sustaining HPV vaccination programs. Furthermore, among programmatic challenges, the initial training of healthcare professionals (HCWs) prior to the introduction is deemed insufficient. National stakeholders in Africa have emphasized the need for refresher training and capacity building of the healthcare workforce for sustained implementation.</div>\n<div>\n Study Objectives: Therefore, using a multi-pronged approach, our study will 1) generate local data on vaccination coverage, HPV infection prevalence and HPV vaccination impact using first-void urine (FVU) in Kenya, Senegal and Uganda, 2) investigate training challenges among HCWs at the national and district level, 3) assess gaps in HCWs' training in Kenya and Uganda.</div>\n<div>\n Study Methodology: This study adopts a multiple-methods approach addressing the above stated objectives. To address the objective of measuring HPV infection prevalence and impact using first void urine, we will use an observational cross-sectional study design to collect samples in Kenya including HPV vaccinated females as part of Gavi demonstration project, and adolescent females vaccinated under national immunization program and control groups for respective study groups. To address the objectives of investigating training challenges among HCWs at the national and district level, we will adopt a mixed-method study design to conduct survey and in-depth interviews with healthcare workers at the health facility. Identical studies will be conducted in Senegal and Uganda.</div>\n<div>\n Expected Outcome/Results: This study aims to evaluate the long-term immune response induced by the HPV vaccine and assess infection prevalence using a non-invasive first-void urine sampling device. By measuring vaccine impact in targeted settings, the study will generate local data on vaccine effectiveness and impact. Additionally, it will explore the feasibility of implementing similar studies at the host institute to facilitate knowledge transfer and skill development in conducting such sampling methods. Furthermore, the study will identify key challenges in training healthcare workers, essential for the successful implementation of HPV vaccination programs. It will also propose sustainable training approaches and methods for assessing healthcare workers' knowledge to ensure program effectiveness and sustainability.</div>\n
      • study_title<p>\n Generating local data on HPV vaccination impact and training needs at the level of vaccine implementers – A feasibility study</p>\n
      • laymans_summary<div>\n This study aims to understand how well HPV vaccination programs are working and to identify areas where healthcare workers may need more training in Kenya, Uganda, and Senegal. This protocol will specifically cover activities in Kenya. The primary goal is to gather information on the effectiveness of HPV vaccines and assess the training of healthcare workers who administer them. </div>\n<div>\n To measure the vaccine's impact, the study will collect urine samples from both vaccinated and unvaccinated girls and women in the three countries. These samples will be tested to see how well the vaccine is helping the body build long-term protection and to track HPV infection rates 126 among the participants.</div>\n<div>\n The study will also explore training challenges faced by healthcare workers involved in giving the HPV vaccine. Through surveys and interviews, researchers will identify gaps in knowledge and training to understand what improvements are needed. </div>\n<div>\n The findings are expected to provide important local data on vaccine coverage, HPV infection rates, and immune responses. Additionally, the study will offer suggestions on how to improve healthcare worker training for more effective HPV vaccination programs. The research will follow ethical standards to protect participant privacy, and everyone will have the option to withdraw at any time. Ultimately, this work aims to strengthen HPV vaccination efforts and improve training for those who deliver the vaccines.</div>\n
      • short_titleHPV vaccine feasibility study
      • protocol_noECCT/25/02/02
      • version_no4.4
      • date_of_protocol20-09-2024
      • study_drugHPV vaccine feasibility study
      • disease_conditionHumanpapillomavirus infection
      • 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_name(Colli-Pee® 20 mL device, Novosanis, CE marked
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.org
      • applicant_covering_letter1
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      • applicant_detailed_budget1
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      • declaration_applicantDr. Catherine Kiptiness
      • declaration_date105-02-2025
      • declaration_principal_investigatorProf Nelly Mugo
      • declaration_date205-02-2025
      • placebo_presentNo
      • study_objectives<p>\n 1) To demonstrate feasibility to measure vaccine induced long-term immune response (vaccination status) and infection prevalence using first-void urine sample in Gavi pilot vaccinated cohort</p>\n<ul>\n <li>\n To demonstrate feasibility to measure vaccine induced immune response and infection prevalence using first-void urine sample in National Immunization Program vaccinated cohort</li>\n <li>\n To assess the feasibility (implementation aspect) of conducting such studies in various African settings</li>\n</ul>\n<p>\n 2) Investigate training challenges among HCWs on HPV vaccination</p>\n<ul>\n <li>\n Identify and understand challenges to implement training among implementers or trainers</li>\n</ul>\n<div>\n 3) Assess gaps in HCWs’ training</div>\n<ul>\n <li>\n To standardize HPV vaccine barometer survey (i.e., to determine level of knowledge among HCWs)</li>\n</ul>\n
      • principal_inclusion_criteria<p>\n <strong><u>INCLUSION CRITERIA</u></strong></p>\n<p>\n <strong><u>Inclusion criteria for the Gavi pilot cohort</u></strong></p>\n<ul>\n <li>\n  Female age 18 – 30 years who were included in the pilot vaccination of the Gavi demonstration program cohort</li>\n <li>\n  Willing to give informed consent to the research team and fill out a short survey</li>\n</ul>\n<p>\n <strong><u>Inclusion criteria for National Immunization Program (NIP) cohort</u></strong></p>\n<ul>\n <li>\n Young adolescents and adults (targeted by the NIP)</li>\n <li>\n Willing to give informed consent to the research team and obtain parental consent and fill out a short survey</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong><u>EXCLUSION CRITERIA</u></strong></p>\n<ul>\n <li>\n Pregnancy – performance of antibody detection in urine sample of a pregnant women has not been studied</li>\n <li>\n Immunocompromised women due to lower immune response</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n To demonstrate feasibility to measure vaccine induced long-term immune response (vaccination status) and infection prevalence using first-void urine sample in Gavi pilot vaccinated cohort</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • 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_other1
      • trial_other_specifyObservational cross-sectional study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span background-color:=\"\" font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has over 100 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc). Principal Investigator: Dr. Nelly R. Mugo MBChB, MMED, MPH Site Principal Investigator: Dr. Kenneth Ngure BScN, MPH, MSc, PhD Site Co investigator: Lynda Oluoch & </span>Dr. Betty W. Njoroge: <span font-size:=\"\" style=\"background-color: rgb(249, 249, 249); color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">MBChB, MSc, MPH Sub investigators: Dr. Catherine Kiptinness, BPharm, MPH, Site pharmacist of Record, Site Coordinator</span></p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study is being done in Kenya</span></p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Uganda - Approved on 28 Oct 2024; Single site</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration12 months
      • design_controlled_randomisedNo
      • 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_comparatorUnvaccinated girls
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR PHRD( (THIKA) PROJECT
      • single_site_physical_addressThika Section 9, OAU Road, Near Thika Nursing home
      • single_site_contact_personDr. Catherine Kiptinness
      • single_site_telephone+254 67222561
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listKenya, Uganda and Senegal.
      • data_monitoring_committeeNo
      • total_enrolment_per_site400
      • total_participants_worldwide1200
      • 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_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_nameProf. Nelly
      • investigator1_middle_name
      • investigator1_family_nameMugo
      • investigator1_qualificationPrincipal Clinical Research Scientist, Center for Clinical Research
      • investigator1_professional_addressKenya Medical Research Institute (KEMRI) Nairobi, Kenya
      • investigator1_telephone0733629665
      • investigator1_emailrwamba@uw.edu
      • organisations_transferred_Yes
      • number_participants400
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      • approval_date29-04-2025
      • submitted1
      • deleted0
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      • date_submitted11-03-2025
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      • initial_date_submitted05-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
      • final_report(null)
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      • quantity_imported(null)
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      • balance_site(null)
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      • modified2025-04-29 10:55:46
      • created2025-01-24 08:23:02
      • total_sites1
      • ecitizen_invoice350320
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        • id1224
        • application_id1507
        • given_nameProf Kenneth
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        • family_nameNgure
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        • telephone0722362219
        • emailkngure@pipsthika.org
        • created2025-02-04 14:47:03
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      • 0(array)
        • id1838
        • application_id1507
        • county_id(null)
        • site_name
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        • id803
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        • sponsorMERCK SHARP & DOHME LLC
        • sponsor_typeOthers
        • contact_personProf Nelly Mugo
        • addressKenya Medical Research Institute (KEMRI) Nairobi, Kenya
        • telephone_number+254 67222561
        • fax_number
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        • email_addressrwamba@uw.edu
        • created2025-02-04 14:47:03
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