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• applications(array)
  • 0(array)
    • Application(array)
      • id832
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n Sub-Saharan Africa has a high rate of new HIV infections. Each year, over two million people are reported to be newly infected, the majority of whom are young African women (under age 30). Women account for more than half of the new infections in Africa. They also face a disproportionate burden of sexually transmitted infections (STIs). The consequences of bacterial STIs on sexual and reproductive health can be profound. This study seeks to evaluate the effectiveness of doxycycline post-exposure prophylaxis (dPEP) to reduce STIs in HIV-uninfected women aged 18 – 30 years who are taking HIV pre-exposure prophylaxis (PrEP) in Kisumu, Kenya. The study aims to assess whether dPEP is acceptable, safe, and tolerable by understanding challenges and motivators of dPEP use and adherence to dPEP and PrEP We will conduct an open-label randomized trial of dPEP versus standard of care among 446 women taking PrEP and follow them for 12 months. We will employ a mixed methods research approach, including use of quantitative questionnaires, focus group discussions (FGDs), short message service (SMS) and individual indepth interviews (IDIs) to study acceptability and changes in sexual behavior due to dPEP. We will collect data specific to women to evaluate if dPEP is effective, safe, acceptable, tetracycline resistance inducing, and cost effective to inform public health policy.</p>\n
      • study_title<p>\n PrEP and dPEP: Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis</p>\n
      • laymans_summary<p>\n In recent times, young women in Africa are twice as likely to acquire a new HIV infection compared to their male counterparts. They are also more affected with multiple health risks from common sexually transmitted infections like gonorrhea, chlamydia and syphilis which are all preventable and treatable. PrEP is known to prevent HIV when taken as prescribed. Past research has also shown that doxycline medication can treat STIs like chlamydia, syphilis and gonorrhea. We would therefore like to find out whether using dPEP among young Kenyan women already taking PrEP will reduce disease burden in this group. We will carry out an investigation to compare one group taking dPEP with another group receiving standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 women taking PrEP (1:1 allocation, 223 per group). We will target women from ages 18 to 30 years old and the study will take place in Lumumba and Jaramogi, Oginga Odinga Teaching and Referral Hospital. We will follow up the women for 12 months. The study will aim to assess whether dPEP is acceptable, safe, and tolerable by understanding challenges and motivators of dPEP use and adherence to dPEP and PrEP. Additionally we will evaluate the cost and impact of using dPEP in controlling new infections and complications. We will carry out indepth interviews, focus group discussions with women on PrEP and also ask them questions to understand their study acceptability and changes in their sexual behavior due to dPEP</p>\n
      • short_titlePrEP and dPEP
      • protocol_noECCT/19/11/02
      • version_no2.0
      • date_of_protocol24-09-2019
      • study_drugDoxycycline capsules
      • disease_conditionSexually Transmitted Infections
      • 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_nameDoxycycline hyclate 100mg
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaachoka@kemri-ucsf.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
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      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
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      • 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_applicantP.O BOX 614-40100
      • declaration_date111-11-2019
      • declaration_principal_investigatorPrincipal Investigator
      • declaration_date211-11-2019
      • placebo_presentNo
      • study_objectives<p>\n 1. Evaluate the effectiveness of doxycycline post-exposure prophylaxis (PEP) to reduce STI infections in HIV-uninfected Kenyan women taking HIV PrEP</p>\n<p>\n 2. Assess the safety, tolerability, and acceptability of dPEP</p>\n<p>\n 3. Assess adherence to dPEP</p>\n<p>\n 4. Investigate the impact of dPEP on tetracycline resistance in N. gonorrhoeae and C. trachomatis</p>\n<p>\n 5. Measure the cost of dPEP and estimate the cost per case averted, budget impact, and affordability.</p>\n
      • principal_inclusion_criteria<p>\n Inclusion criteria 1) Willing and able to give written informed consent 2) Age ≥18 years and 30 years old 3) Female sex at birth 4) HIV-seronegative, according to national HIV testing algorithm 5) Has a current prescription for PrEP according to the national guidelines of Kenya.</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria 1) Pregnant 2) Breastfeeding a child 3) Allergy to tetracycline class 4) Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, phenytoin, and warfarin. 5) Recent use of prolonged (more than 14 day course) antibiotics in the month prior to enrollment 6) Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee.</p>\n
      • primary_end_points<p>\n Primary Analysis: We will analyze the composite endpoint of any of the three STIs as well as for C. trachomatis alone, and we will continue until there are sufficient C. trachomatis events (n=66) given the high incidence of this pathogen and its importance for reproductive morbidity (the consequence of which will be that the total number of events in the composite of C. trachomatis, N. gonorrhoeae, and syphilis will be greater than n=66). Analyses will be intention-to-treat, including women whether or not they continue dPEP (as well as whether or not they continue PrEP). STI incidence will be compared between arms using repeated measures analysis of proportions (e.g., generalized estimating equations [GEE]), given possibility of repeat infection within individuals. Per-protocol and adjusted analyses will be done as needed, controlling for potential confounders: demographics (e.g., age, education), sexual behavior (e.g., condom use, # partnerships), and beliefs (e.g., risk perception, dPEP/PrEP efficacy). SAS or R will be used.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyopen-label randomized trial of dPEP versus standard of care
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Receptionist 1-Diploma in secretarial studies</p>\n<p>\n Study nurses-2- Diploma in Nursing</p>\n<p>\n Study Clinicians-2- Diploma in Clinical medcine</p>\n<p>\n Pharmaceutical Technologists-2- Dploma in Phrmaceuticl Technology</p>\n<p>\n Pharmacist- 1- B.Pharm</p>\n<p>\n Community liason officer-1- Bachelors in Community Health</p>\n<p>\n Research Assistants-2- Diploma in Community Health</p>\n<p>\n Data Mangaer-1- BSc Statistics</p>\n<p>\n Data Clerks-1- Diploma in Statistics</p>\n<p>\n Medical Laboratory Technologist-1- Diploma in Medical laboratory</p>\n<p>\n Administrator-1- BBM</p>\n<p>\n HRM-1- Human resources management</p>\n<p>\n Study coordinator-1-</p>\n<p>\n Co-Investigators-2-</p>\n<p>\n Principal Investigator-1</p>\n
      • other_details_explanation<p>\n The trial will be conducted in Kenya not in the host country.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Unit 23rd October 2019</p>\n<p>\n University of Washington IRB 07 November 2019</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNone Doxycycline capsules
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/CMR/RCTP Kisumu-Lumumba Sub-County Hospital
      • single_site_physical_addressP.O BOX 614-40100
      • single_site_contact_personProfessor Elizabet Bukusi
      • single_site_telephone0733 617 503
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site446
      • total_participants_worldwide446
      • 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_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_nameDr.Elizabeth Bukusi
      • investigator1_middle_nameAnn
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
      • investigator1_professional_addressP.O Box 614-40100
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_No
      • number_participants446
      • notification<p>\n We have requested for an invoice from PPB to facilitate the payment of application fee.</p>\n<p>\n Once we have received the invoice, we will proceed to make the payment promptly.</p>\n<p>\n Thank you,</p>\n<p>\n Eric,</p>\n<p>\n  </p>\n
      • approval_date31-01-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-06-2020
      • 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)
      • modified2025-03-18 11:54:30
      • created2019-11-11 14:03:09
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id514
        • application_id832
        • given_nameDr.Elizabeth Bukusi
        • middle_nameAnn
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
        • professional_addressP.O Box 614-40100
        • telephone0733617503
        • emailebukusi@rctp.or.ke
        • created2019-11-11 14:09:20
        • modified2020-06-17 11:29:13
    • SiteDetail(array)
      • 0(array)
        • id673
        • application_id832
        • county_id(null)
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        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-11-11 14:09:20
        • modified2020-06-17 11:29:13
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id402
        • application_id832
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personJared Beaten
        • addressUniversity of Washington, Seattle, WA
        • telephone_number001 206-520-3808
        • fax_number
        • cell_number001 206-520-3808
        • email_addressjbaeten@uw.edu
        • created2019-11-11 14:09:20
        • modified2020-06-17 11:29:13
  • 1(array)
    • Application(array)
      • id474
      • user_id321
      • trial_status_id7
      • abstract_of_study<div style=\"width: 80%\">\n <div style=\"font-size: 12px; width: 698.391px;\">\n <p style=\"margin-left: 1.5in;\">\n  </p>\n </div>\n</div>\n<p class=\"Normal1\" style=\"text-align:justify\">\n <strong>Purpose:</strong><b> </b>To determine whether isoniazid (INH) reduces the risk of <i>Mycobacterium tuberculosis</i> (MTB) infection in HIV-exposed but uninfected (HEU) children. To determine the epidemiologic and immunologic correlates of MTB infection in HEU.<o:p></o:p></p>\n<p>\n <strong>Study Population: </strong>HIV-exposed uninfected (HEU) infants and their mothers</p>\n<p>\n <strong>Study Size: </strong>300 infants, 150 per arm </p>\n<p>\n <strong>Treatment Regimen:</strong> Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months. </p>\n<p>\n <strong>Study Duration:</strong> 3 years (12 months of follow-up for each participant)</p>\n<p>\n <strong>Primary Objectives:</strong></p>\n<p>\n AIM: 1 Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an IGRA assay to determine MTB infection status.</p>\n<p>\n <strong>Secondary Objectives:</strong></p>\n<p>\n AIM 2: Determine epidemiologic correlates of MTB infection among infants enrolled in the RCT.</p>\n<p>\n AIM 3: Determine immune correlates of risk of primary MTB infection and their potential interactions with INH. Assays will include infant peripheral blood BCG-specific T-cell responses at approximately 6 weeks post BCG vaccination, and maternal breast milk MTB-specific T-cell responses at approximately 6 weeks postpartum.</p>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<p>\n Investigate the impact of IPT on a combined endpoint of MTB infection, TB disease, and death among HEU infants</p>\n<p>\n <strong>Study Sites:                </strong>Maternal Child Health (MCH) clinics in Western Kenya (Kisumu, Ahero and Bondo).</p>\n
      • study_title<p>\n Preventing <em>Mycobacterium Tuberculosis</em> Infection in HIV-Exposed Infants</p>\n<p align=\"center\">\n  </p>\n
      • laymans_summary(null)
      • short_titleInfant TB Infection Prevention Study (“iTIPS”)
      • protocol_noECCT/16/03/02
      • version_no1.0
      • date_of_protocol06-08-2015
      • study_drugisoniazid
      • disease_conditionMycobacterium tuberculosis infection
      • 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_nameisoniazid
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssmlacourse@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJohn Kinuthia
      • declaration_date125-01-2016
      • declaration_principal_investigatorGrace John-Stewart
      • declaration_date225-01-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n HIV-exposed uninfected infants who meet all of the following criteria are eligible for inclusion in this study:</p>\n<p style=\"margin-left:.5in;\">\n ●            Aged 6 weeks within (+/- 4 weeks)</p>\n<p style=\"margin-left:.5in;\">\n ●            Born to HIV-infected mothers</p>\n<p style=\"margin-left:.5in;\">\n ●            Not premature and over 2.5 kg</p>\n
      • principal_exclusion_criteria<p>\n HIV-exposed uninfected infants who meet any of the following criteria will be excluded from this study:</p>\n<p style=\"margin-left:.5in;\">\n ●            Infants with known exposure to active TB in household at time of enrollment</p>\n<p style=\"margin-left:.5in;\">\n ●            Premature and < 2.5 kg</p>\n
      • primary_end_points<p style=\"margin-left:.25in;\">\n Mycobacterium tuberculosis infection as detected by interferon gamma release assays (IGRA) at 12 months post-enrollment. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The facilities are County teaching and Referral Hospitals, which are equipped to manage emergencies with the below listed Qualified and licensed professionals involved directly to the iTIPS Study.</p>\n<p>\n 1 study coordinator</p>\n<p>\n 1 nurse with pediatric phlebotomy experience</p>\n<p>\n 1 retention counselor</p>\n<p>\n We will plan on enrolling primarily at Kisumu County Hospital, and will only enroll at Ahero and Bondo sites if there are issues with timely enrollment at Kisumu County Hospital.</p>\n
      • other_details_explanation<p>\n Children living with HIV-infected household members are at increased risk of TB exposure.Among children, accelerated progression from latent TB infection to active TB disease is associated with immunosuppression and younger age.<span style=\"font-size: 10px;\"> </span>Kenya is one of 22 high TB burden countries with a generalized TB epidemic affecting young adults. A large observational study from AMPATH in Western Kenya longitudinally estimated TB disease incidence in HIV-infected children and noted a staggeringly high 17.1% annual incidence of active TB in a cohort with a median age of 1.0 year at enrollment.<span style=\"font-size: 10px;\"> </span>TB disease prevalence was also high at 3.6% on enrollment. </p>\n<p>\n This study is designed to determine if isoniazid reduces the risk of Mycobacterium tuberculosis infection in HIV-exposed uninfected infants. In order to answer this question, this trial must be conducted in a high HIV/TB burden area.</p>\n<p>\n This study leverages pre-existing research team experience and infrastructure in western Kenya. University of Washington and Kenyan researchers have worked collaboratively on epidemiologic and immunologic studies examining HIV and co-infections in maternal-infant cohorts for >25 years.  </p>\n
      • other_details_regulatory_notapproved<p>\n N/A. Â We have approval from the UON-KNH ERC and University of Washington IRB.</p>\n
      • other_details_regulatory_approved<p>\n We have approval from the UON-KNH ERC 13Jan2016 - 12Jan2017.</p>\n<p>\n  </p>\n<p>\n We have approval from the University of Washington IRB 12Jan2016 - 11Jan2017. </p>\n
      • other_details_regulatory_rejected<p>\n N/A. We have had no rejections.</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 years (12 months of follow-up for each participant)
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorno INH (non-blinded, non-
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifypyroxidine will be given to children randomized to isoniazid
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteThere is no set enrollment at each site.
      • total_participants_worldwide300 (150 infants in each arm)
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyHIV-exposed uninfected infants aged 6 weeks will be enrolled.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJohn
      • investigator1_middle_name
      • investigator1_family_nameKinuthia
      • investigator1_qualificationMBChB, MMed, MPH
      • investigator1_professional_addressHead, Research and Programs Kenyatta National Hospital PO Box 20723, Nairobi, Kenya
      • investigator1_telephone+254-722-799-052
      • investigator1_emailkinuthia@u.washington.edu
      • organisations_transferred_No
      • number_participants300 (150 infants in each arm)
      • notification
      • approval_date03-06-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-03-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Primary outcome assessment occurred at 12 months post-randomization. Excluding the 2 children who were found to be HIV-infected, 287 infants completed the study. 264 of the 287 infants who exited the study have QFT results and/or TST results available. QFT results are available for 246 infants, of which 240 are negative (125 INH, 115 No INH), 3 indeterminate (3 INH, 0 No INH), and 3 (1.2%) positive (2 INH, 1 No INH). TST testing was initiated 26 Feb 2018, and was performed on 187 children, of which 134 were <5 mm (72 INH, 62 No INH), 28 5-<10 mm (13 INH, 15 No INH), 21 10-<15 mm (7 INH, 14 No INH), and 4 15-19 (1 INH, 3 No INH) mm. Using a 10 mm cut-off, 25 (13.4%) children are TST+ (8 INH, 17 No INH). One infant was clinically diagnosed with TB by MOH clinical staff with clinical features compatible with TB including failure to thrive, abnormal CXR, and improvement of symptoms after TB treatment was initiated in the INH arm. The prevalence of MTB infection by QFT or TST (<u>></u> 10 mm) among children with either or both results is 10.6% (28/263).</p>\n<p>\n In a modified intention to treat analysis excluding the 2 children who were diagnosed with HIV, the prevalence of MTB infection (by TST or QFT) was approximately 2-fold lower in the INH group compared to the No INH group, though not statistically significant (INH: 10/131 (7.6%) vs. No INH: 18/133 (13.5%), RR 0.56 (95% CI 0.27-1.18), p=0.13). This trend for reduced prevalence of MTB infection in the INH vs. No INH arm was stronger when evaluating TST-positivity alone (8.6% versus 18.1%, p=0.07).</p>\n<p>\n Similarly, there was a trend for lower cumulative incidence of MTB infection in the in the INH group compared to the No INH group (7.0 vs 13.5 per 100 person years, HR 0.54 (95% CI 0.25-1.16), p=0.114). Analyses of a composite endpoint of MTB infection, death, or TB were also similar and driven primarily by MTB infection.</p>\n<p>\n In per protocol analyses, further excluding 5 infants in INH arm who never received INH dose, and 1 infant in No INH arm who initiated INH due to TB exposure resulted in similar results to the modified intention to treat analyses.</p>\n<p>\n In summary, isoniazid appears to reduce the risk of primary MTB infection in HIV-exposed uninfected children. The final primary endpoint results do not meet statistical significance, however there is a strong trend for these findings. We ask that these results not be widely shared while they are still preliminary.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-04-24 23:58:10
      • created2016-01-25 09:30:34
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id312
        • application_id474
        • given_nameGrace
        • middle_name
        • family_nameJohn-Stewart
        • qualificationMD, PhD
        • professional_address325 9th Avenue, Box 359909 Seattle, WA 98104 USA
        • telephone+1-206-543-4278
        • emailgjohn@u.washington.edu
        • created2016-01-25 09:40:07
        • modified2016-03-12 03:15:23
    • SiteDetail(array)
      • 0(array)
        • id371
        • application_id474
        • county_id42
        • site_nameKisumu East District Hospital
        • physical_addressOpposite Kisumu Sports Ground, Paul Mbuya Rd, Kisumu, Kenya
        • contact_details P.O Box 1818
        • contact_personDr Amos Otedo
        • site_capacity(null)
        • misc(null)
        • created2016-01-25 09:40:07
        • modified2016-03-12 03:15:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id372
        • application_id474
        • county_id42
        • site_nameAhero County Hospital
        • physical_address69 off Nairobi Kericho High way Rd (Near Nyando River )
        • contact_details P. O .Box 169-40101
        • contact_personDr. Joram Ouma
        • site_capacity(null)
        • misc(null)
        • created2016-01-25 12:09:02
        • modified2016-03-12 03:15:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id373
        • application_id474
        • county_id42
        • site_nameBondo sub-County Hospital
        • physical_address89 off Bondo Siaya Rd next to police station
        • contact_detailsP.O. Box 89
        • contact_personDr. Felix Tidi
        • site_capacity(null)
        • misc(null)
        • created2016-01-25 12:11:23
        • modified2016-03-12 03:15:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id245
        • application_id474
        • sponsorThrasher Research Fund
        • sponsor_type(null)
        • contact_personAllison F. Martinez
        • addressThrasher Research Fund 68 S. Main St., Suite 400 Salt Lake City, UT 84101, USA
        • telephone_number+1-801-240-4753
        • fax_number+1-801-240-1625
        • cell_number+1-801-240-4753
        • email_addressMartinezAF@Thrasherresearch.org
        • created2016-01-25 09:40:07
        • modified2016-03-12 03:15:23
  • 2(array)
    • Application(array)
      • id801
      • user_id301
      • trial_status_id1
      • abstract_of_study<p>\n <strong><u>Background:</u></strong>Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths,and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced certain maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality.</p>\n<p>\n <strong><u>Hypotheses:</u></strong>The trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.</p>\n<p>\n <strong><u>Study Design Type:</u></strong>Randomized, placebo-controlled, parallel multicenter clinical trial. Women in labor will be randomized with one-to-one ratio to intervention/placebo.</p>\n<p>\n <strong><u>Population:</u></strong>Pregnant women in labor at ≥28 weeks gestational age with a live fetus pregnancy who plan to deliver vaginally in a facility. Women with evidence of chorioamnionitis or other infection requiring antibiotic therapy (not prophylaxis) at time of eligibility, allergy to azithromycin, use of azithromycin, erythromycin or other macrolide within 3 days of enrollment, known arrhythmia or cardiomyopathy, or plan for cesarean section delivery prior to enrollment will be excluded.</p>\n<p>\n <strong><u>Intervention:</u></strong>A single, prophylactic intrapartum oral dose of 2 g azithromycin.</p>\n<p>\n <strong><u>Comparison:</u></strong>A single intrapartum oral dose of an identical appearing placebo</p>\n<p>\n <strong><u>Outcomes:</u></strong></p>\n<p>\n <strong><em>Primary outcomes</em>:</strong>1) Incidence of maternal death or sepsis and 2) incidence of intrapartum/neonatal death or sepsis.</p>\n<p>\n <strong><em>Secondary outcomes</em></strong>:Individual components of the primary outcomes (maternal death, maternal sepsis, intrapartum/neonatal death, neonatal sepsis), neonatal death/sepsis, neonatal deaths due to sepsis, and all-cause neonatal death; the primary maternal outcome in a high-risk for infection population; specific maternal infections; use of subsequent maternal antibiotic therapy; pyloric stenosis; health care resource utilization; culture-positive infections and resistance; in an ancillary surveillance study,  incidence of antimicrobial resistance and microbiome diversity. </p>\n
      • study_title<p>\n Prevention of Maternal and Neonatal Death/Infections with a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-Income Countries): a Randomized Controlled Trial</p>\n
      • laymans_summary<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">The purpose of the A-PLUS study is to learn whether an antibiotic, called azithromycin, given by mouth to pregnant women during labor can reduce the risk of infection for the woman and her baby. A total of 34,000 women will be enrolled in this study from eight sites in sub-Saharan Africa, South Asia, and Latin America.<o:p></o:p></span></p>\n<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">The target population are pregnant women of legal age of consent who labor with one or more live fetuses and a pregnancy of ≥28 weeks, plan to deliver vaginally in a health facility, have no known infections that require antibiotics, have no known problems taking azithromycin or similar antibiotics (such as amoxicillin), and have not used azithromycin, erythromycin, or similar antibiotic in the past 3 days.<o:p></o:p></span></p>\n<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">Before participating, participants will be provided with information about the study procedures and given an opportunity to ask questions. If they qualify and agree to participate, they will be asked to sign a form to indicate consent.<o:p></o:p></span></p>\n<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">Participants will be assigned to either the treatment group or the control group randomly, like flipping a coin or choosing a grain of rice from a bag. The women in the <u>treatment</u> group will take four 500 mg azithromycin pills. For comparison, the women in the <u>control</u> group will take four pills called placebo that look identical to azithromycin but do not contain any medication. Neither participants nor the study staff will know whether they were assigned to the treatment or control group. Participants will receive care during your labor, delivery, and recovery from the health facility staff, according to the local standard of care.<o:p></o:p></span></p>\n<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">While at the health facility for deliver, the study team will also collect: information about labor and delivery; information about the baby, such as birthweight and health status at the time of delivery. If study participants develop an infection before being discharged from the health facility, a sample will be taken from the site of the infection. Participants may also be asked to provide a blood sample.<o:p></o:p></span></p>\n<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">After delivery, the study team will visit a total of three times at home at 3 days, 1 week and 6 weeks after delivery or in the hospital if the participant or the baby is in hospital. The study team will assess for signs of infection in the mother and baby and will collect a specimen to help identify the bacteria involved. This may be a sample of pus, urine, or blood.  The visits will take approximately 30 minutes.<o:p></o:p></span></p>\n<p>\n <span style=\"font-size: 9pt; font-family: Arial, sans-serif;\">The team will access and collect information from the medical records at the health facilities where care was received.  The information collected from medical records will be coded with a number to protect the identity of study participants. The local research staff has been selected because of their skills, knowledge, and familiarity with the community and should be contacted between visits if there are any questions or concerns.<o:p></o:p></span></p>\n
      • short_titleThe A-PLUS study
      • protocol_noECCT/19/06/02
      • version_no1.1
      • date_of_protocol19-01-2019
      • study_drugCinfa azithromycin 500 mg film-coated tablets
      • disease_conditionMaternal and Neonatal Death/Infections
      • 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_nameazithromycin
      • product_type_medical_device_name
      • comparatorYes
      • comparator_namePlacebo
      • comparator_registeredNot applicable
      • comparator_countriesNot applicable
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdrpaulnyongesa@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantD Paul John Nyongesa Obanda
      • declaration_date106-06-2019
      • declaration_principal_investigatorProf Fabian Esamai
      • declaration_date206-06-2019
      • placebo_presentYes
      • study_objectives<h2>\n 1.1Primary Specific Aims</h2>\n<p style=\"margin-left:.5in;\">\n To test the effectiveness of a single dose of prophylactic intrapartum azithromycin compared to placebo in reducing the risk of the composite outcome of maternal death or sepsis. To separately test the effectiveness of a single oral dose of intrapartum azithromycin prophylaxis (2 g) compared to placebo in reducing the risk of the composite outcome of intrapartum/neonatal death or sepsis<strong><em>. Both groups will receive the routine or usual care provided at the facility during and after labor. This will be ensured through training of all nurses on maternal and newborn care using the National guidelines and protocols as provided for by the Ministry of Health viz Basic Paediatric Protocols 2016,</em> <em>National Guidelines for Quality Obstetrics and Perinatal Care and National Guidelines on Essential Newborn Care.</em></strong></p>\n<p>\n  </p>\n<h2>\n 1.2Secondary Specific Aims</h2>\n<p>\n The single dose of intrapartum  azithromycin prophylaxis (2 g) will be compared to placebo to accomplish the following secondary aims:</p>\n<ul>\n <li>\n <u>Main Secondary Aim for Women at High Risk for Infection Cohort:</u>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n To evaluate whether the risk of maternal death or sepsis differs among laboring women with and without high-risk for infection (high risk is defined as women with prolonged labor [≥18 hours] and/or prolonged membrane rupture [≥8 hours]).</li>\n </ol>\n </li>\n <li>\n <u>Other secondary specific Aims:</u></li>\n</ul>\n<ol style=\"list-style-type:lower-alpha;\">\n <li value=\"2\">\n To evaluate the effectiveness in reducing the risk of individual components of the primary composite endpoints (i.e., maternal death, maternal sepsis, intrapartum/neonatal death, neonatal sepsis including specifically all-cause neonatal deaths and neonatal deaths due to sepsis).</li>\n <li value=\"3\">\n To evaluate the effectiveness on the risk of intrapartum/neonatal death or sepsis in infants of laboring women at high-risk for infection because of prolonged labor (≥18hours) and/or prolonged membrane rupture (≥8 hours).</li>\n <li value=\"4\">\n To evaluate the effectiveness on the risk of maternal infections including clinical chorioamnionitis, endometritis, wound infections (perineal or subsequent cesarean), abdominal or pelvic abscess, mastitis/breast abscess, pyelonephritis and pneumonia in all laboring women as well as in those at high-risk for infection.</li>\n <li value=\"5\">\n To evaluate the effectiveness in reducing the use of subsequent maternal antibiotic therapy from randomization to 6 weeks for any reason in all laboring women as well as in those at high-risk for infection.</li>\n <li value=\"6\">\n To compare the use of health care resources. Use of health care resources will be measured in terms of maternal and neonatal duration of hospital stay, unscheduled clinic or ER visits, readmissions, and admission to special care units/intensive care units in all laboring women and newborns as well as in those at high-risk for infection.</li>\n <li value=\"7\">\n To assess maternal GI symptoms (e.g., nausea, vomiting, and diarrhea) and other reported side effects, as well as infant pyloric stenosis and type of culture positive infections (antimicrobial resistance and maternal and infant microbiome diversity are compared in an ancillary study).</li>\n <li value=\"8\">\n To determine whether the effect on each of the primary outcomes differs by region (Africa, Latin America or Asia), any other antibiotic use during labor, and mode of delivery (cesarean or vaginal). Note that antibiotic use will not include use to treat any infections diagnosed after randomization as those will be outcomes.</li>\n</ol>\n
      • principal_inclusion_criteria<ul>\n <li style=\"margin-left: 0.5in;\">\n Pregnant women in labor ≥28 weeks GA (by best estimate) with a pregnancy with one or more live fetuses who plan to deliver vaginally in a facility.</li>\n <li style=\"margin-left: 0.5in;\">\n Admitted to health facility with clear plan for spontaneous or induced delivery.</li>\n <li style=\"margin-left: 0.5in;\">\n Live fetus must be confirmed via a fetal heart rate by Doptone prior to randomization.</li>\n <li style=\"margin-left: 0.5in;\">\n Have provided written informed consent at gestation 28 weeks or beyond during antenatal care or home visits by the study field staff. However,  verbal  re-confirmation will be done  at the time of randomization</li>\n</ul>\n
      • principal_exclusion_criteria<ul style=\"margin-left: 40px;\">\n <li>\n Non-emancipated minors.</li>\n <li>\n Evidence of chorioamnionitis or other infection requiring antibiotic therapy at time of eligibility (however, women given single prophylactic antibiotics with no plans to continue after delivery should not be excluded).</li>\n <li>\n Arrhythmia or known history of cardiomyopathy.</li>\n <li>\n <strong><em>Allergy to azithromycin or other macrolides that is self-reported by the pregnant woman or documented in a recent or any medical record.</em></strong></li>\n <li>\n <strong><em>Any use of azithromycin, erythromycin, or other macrolide in the 3 days or less prior to randomization as established during the enrolment process through history taking.</em></strong></li>\n <li>\n Plan for cesarean delivery prior to randomization.</li>\n <li>\n Preterm labor undergoing management with no immediate plan to proceed to delivery.</li>\n <li>\n Advanced stage of labor of 10cm cervical dilatation and pushing <strong>or</strong> too distressed to understand, confirm, or give informed consent <strong>regardless </strong>of cervical dilation.</li>\n <li>\n Any other medical conditions that may be considered a contraindication per the judgment of the site investigator</li>\n <li>\n Previous randomization in the trial.</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n • Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.<br />\n • Neonatal: Incidence of intrapartum/neonatal death or sepsis within 7 days and  4 weeks (28 days) post-delivery in intervention vs. placebo group.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyTherapeutic use (Phase IV)
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>South Asian Sites</strong></p>\n<p>\n <strong>India (Belgaum)</strong></p>\n<p>\n <em>Location:</em>The research site is within the northwestern corner of the southern state of Karnataka, India, with the site coordinating center located in Belgaum.</p>\n<p>\n <em>Setting:</em> There are 18 clusters corresponding to the service areas of 18 primary health centers. Each is managed by a physician medical officer who works with nursing staff and auxiliary nurse midwives in associated sub-centers, the most peripheral outpost of the health care services. There are three tertiary care hospitals and eight secondary care hospitals serving the region as referral hospitals staffed by obstetricians, pediatricians and nurses. In addition to these public sector health facilities, there are several private sector maternity facilities within the site catchment area.</p>\n<p>\n <em>HDI:</em> 0.640</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p>\n <strong>India (Nagpur)</strong></p>\n<p>\n <em>Location</em>: The research site is within the state of Maharashtra, India, with the coordinating center in Nagpur.</p>\n<p>\n <em>Setting</em>:  There are 20 clusters corresponding to the service area of 20 primary health centers, each served by physician medical officers and nurses. These areas include 119 sub-centers where basic maternal and child care are provided. Referral care is provided in ten tertiary hospitals (two public sector and eight private sector), and 129 secondary hospitals (27 public sector hospitals and 102 private nursing homes).</p>\n<p>\n <em>HDI</em>: 0.640</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p>\n <strong>Pakistan</strong></p>\n<p>\n <em>Location: </em>Research sites are in two of five sub-districts within the Thatta district in the southern Sindh province, near the city of Karachi, where the site coordinating center is located.</p>\n<p>\n <em>Setting: </em>The 20 clusters are served by over 75 health facilities, both public sector and private fee-for-service, providing maternal and child health services. This includes 47 primary health clinics, 25 secondary care facilities and 3 referral hospitals. Care in health clinics is typically provided by either paramedical staff, including nurses and lady health visitors or non-specialist physicians.  Obstetricians provide care in referral hospitals.</p>\n<p>\n <em>HDI: </em>0.562</p>\n<p>\n  </p>\n<p>\n <strong>Bangladesh</strong></p>\n<p>\n <em>Location: </em></p>\n<p>\n <em>Setting: </em>12 clusters. This includes x primary health clinics, x secondary care facilities and x referral hospitals.</p>\n<p>\n <em>HDI: </em>0.608</p>\n<p style=\"margin-left:.5in;\">\n  </p>\n<p>\n <strong>sub-Saharan Africa Sites</strong></p>\n<p>\n <strong>Kenya</strong></p>\n<p>\n <em>Team: </em>Irene Marete, Paul Nyongesa, Constance Tenge, Fabian Esamai, Sherri Bucher, Edward Liechty</p>\n<p>\n <em>Location:</em>Within the western region of Kenya in the counties of Busia, Bungoma and Kakamega, with the site coordinating center located in Eldoret.  </p>\n<p>\n <em>Setting:</em>There are 8 clusters served by 23 health facilities, most operated by the government and staffed by nurse-midwives and clinical officers and a single medical officer. Three hospitals in the area function as county referral hospitals. There is a one tertiary teaching and referral hospital in Eldoret for the western region with a newly established training in maternal fetal medicine (MFM). Most physicians are generalists, with  trained obstetricians and pediatricians.</p>\n<p>\n <em>HDI</em>: 0.590</p>\n<p>\n <strong>Zambia</strong></p>\n<p>\n <em>Location</em>: The districts of Kafue and Chongwe located south and east of the capital city of Lusaka, Zambia, where the site coordinating center is located.</p>\n<p>\n <em>Setting</em>: There are ten clusters, eight of which have health posts. Care is provided primarily by nurse midwives in the health posts and by traditional birth attendants for home births. There are three district hospitals and a referral hospital in Lusaka. Specialty physicians are available in the referral hospital only.</p>\n<p>\n <em>HDI: </em> 0.588</p>\n<p>\n  </p>\n<p>\n <strong>Democratic Republic of Congo</strong></p>\n<p>\n <em>Location</em>: The research sites are in the northern province of Equateur, with the site coordinating center in Kinshasa.</p>\n<p>\n <em>Setting</em>: There are 14 clusters, each served by a health center. Care in health centers is provided by nurses. There are three hospitals staffed by physicians, nurse midwives and nurses; no specialty physicians are available.</p>\n<p>\n <em>HDI</em>: 0.457 (note: this is the HDI for the entire country; regional estimates were not available).</p>\n<p>\n  </p>\n<p>\n <strong>Latin American Site</strong></p>\n<p>\n <strong>Guatemala</strong></p>\n<p>\n <em>Location:</em> The Chimaltenango region​is located in the Western Highlands​​ of Guatemala, with the coordinating center in Guatemala City.</p>\n<p>\n <em>Setting:</em> There are 17 clusters served by one referral hospital, 30 ​health centers, and ​42 health posts. Maternal and infant care in the hospital is provided mainly by obstetricians and general physicians, in health centers by physicians and nurses, and in health posts by auxiliary nurses.</p>\n<p>\n <em>HDI:</em>0.650</p>\n<p>\n <strong>Site Coordination Teams</strong></p>\n<p>\n <strong>Democratic Republic of Congo: </strong>Antoinette Tshefu, Adrien Lokangaka, (Kinshasa School of Public Health); Melissa Bauserman, Jackie Patterson, Carl L Bose (UNC Chapel Hill); <strong>Guatemala:</strong> Ana Garces, Lester Figueroa (Instituto de Nutrición de Centro América y Panamá), Nancy F. Krebs (University of Colorado);<strong>Bangladesh</strong>: Rashidul Haque, Masum Billah (icddr,b), William Petri (University of Virgnia); <strong>India (Belgaum): </strong>Shivaprasad S Goudar, Sangappa Dhaded, Avinash Kavi, Manjunath Somannavar, M.C. Metgud (KLE University’s Jawaharlal Nehru Medical College) Frances J. Jaeger, Richard J. Derman (Thomas Jefferson University); <strong>India (Nagpur):</strong> Archana Patel (Lata Medical Research Foundation), P. S. Kalsait, Kunal Kurhe, Patricia L. Hibberd (Boston University); <strong>Kenya</strong>: Fabian Esamai, Irene Marete; Constance Tenge,Paul Nyongesa, Silas Ayunga (Moi University School of Medicine), Edward A. Liechty, Sherri Bucher (Indiana University); <strong>Pakistan: </strong>Sarah Saleem, Farnaz Naqvi, Shiyam Sunder, Zaheer Habib (Aga Khan University), Robert L. Goldenberg (Columbia University); <strong>Zambia</strong>: Elwyn Chomba; Musaku Mwenechanya (University of Zambia); Melody Chiwila (CIDRZ), Waldemar A. Carlo (University of Alabama at Birmingham); <strong>Data Coordinating Center: </strong>Elizabeth M. McClure, Janet L. Moore Norman Goco, Stephen D. Litavecz(RTI International); <strong><em>Eunice Kennedy Shriver</em> National Institute of Child Health and Human Development</strong>: Marion Koso-Thomas, Menachem Miodovnik; <strong>Global Network Chair:</strong></p>\n<p>\n  </p>\n<p>\n <strong>Sites of the Global Network for Women’s and Children’s Health Research</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Location of Site</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n <strong>In-country Institution</strong></p>\n </td>\n <td style=\"width:127px;\">\n <p>\n <strong>US Institution</strong></p>\n </td>\n <td style=\"width:120px;\">\n <p>\n <strong>Senior Foreign Principal Investigator</strong></p>\n </td>\n <td style=\"width:108px;\">\n <p>\n <strong>US Principal Investigator</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Equateur Provence, Democratic Republic of Congo*</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n Kinshasa School of Public Health, Kinshasa</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n University of North Carolina-Chapel Hill</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Antoinette Tshefu</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n Carl Bose</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Kafue and Chongwe Provence, Zambia</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n University Teaching Hospital, Lusaka</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n University of Alabama at Birmingham</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Elwyn Chomba</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n Waldemar Carlo</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Chimaltenango, Guatemala</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n INCAP, Instituto de Nutrición de Centro América y Panamá, Guatemala City</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n University of Colorado School of Medicine</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Ana Garces</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n Nancy Krebs</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Ghatail and Kalihati</strong><strong>, Bangladesh**</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n icddr,b</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n University of Virginia</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Rashidul Haque</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n William Petri</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Belgaum, Karnataka, India</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n Jawaharlal Nehru Medical College, Belgaum</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n Thomas Jefferson University</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Shivaprasad Goudar</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n Richard Derman</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Thatta, Pakistan</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n Aga Khan University, Karachi</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n Columbia University</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Sarah Saleem</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n Robert Goldenberg</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Nagpur, India</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n Lata Medical Research Foundation, Nagpur</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n Boston University</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Archana Patel</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n Patricia Hibberd</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Western Provence, Kenya</strong></p>\n </td>\n <td style=\"width:137px;\">\n <p>\n Moi University, Eldoret, Kenya</p>\n </td>\n <td style=\"width:127px;\">\n <p>\n Indiana University School of Medicine</p>\n </td>\n <td style=\"width:120px;\">\n <p>\n Fabian Esamai</p>\n </td>\n <td style=\"width:108px;\">\n <p>\n Edward Liechty</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Data Coordinating Center</strong></p>\n </td>\n <td colspan=\"2\" style=\"width:263px;\">\n <p>\n RTI International, Durham, NC</p>\n </td>\n <td colspan=\"2\" style=\"width:228px;\">\n <p>\n Elizabeth McClure</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n *Participant in the MNHR since 2013 only</p>\n<p>\n **New participant in the MNHR beginning 2019</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Moi University/Moi Teaching and Referral Hospital Institutional Ethics and Ethics Committee(MU/MTRH IREC)</p>\n
      • other_details_regulatory_approved<p>\n Nil</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration36 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states8
      • number_of_sites8
      • multi_country_listKenya, DRC, Zambia, Bangladesh, Nagpur, Belagavi, Pakistan and Guatemala
      • data_monitoring_committeeYes
      • total_enrolment_per_site532
      • total_participants_worldwide34,000
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Paul Nyongesa
      • investigator1_middle_nameJohn
      • investigator1_family_nameObanda
      • investigator1_qualificationMbChB(U.O.N.), MMed(OB Gyn)(U.O.N.)
      • investigator1_professional_addressCollege of Health Sciences,Moi University,Dept of Reproductive Health Box 4606 30100 Eldoret ,Kenya
      • investigator1_telephone0733 788 063
      • investigator1_emaildrpaulnyongesa@yahoo.com
      • organisations_transferred_No
      • number_participants4250
      • notification
      • approval_date09-06-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy Approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-12-04 09:50:15
      • created2019-06-05 08:01:09
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id501
        • application_id801
        • given_nameProf Fabian Esamai
        • middle_nameOmoding
        • family_nameEsamai
        • qualificationMbChB, MMed(Paed),MPH,PhD
        • professional_addressCollege of Health Sciences,Moi University,Dept of Child Health and Paediatrics Box 4606 30100 Eldoret ,Kenya
        • telephone0733 836 410
        • emailfesamai2007@gmail.com
        • created2019-06-05 08:13:20
        • modified2020-03-13 10:09:42
    • SiteDetail(array)
      • 0(array)
        • id658
        • application_id801
        • county_id39
        • site_nameAlupe, Sirisia, Bokoli
        • physical_addressWestern Kenya
        • contact_detailsBox 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2019-06-05 08:13:20
        • modified2020-03-13 10:09:42
        • County(array)
          • id39
          • county_nameBung\'oma
          • created2012-06-15 10:26:45
          • modified2012-06-15 10:26:45
      • 1(array)
        • id659
        • application_id801
        • county_id40
        • site_nameNambale, Nasewa, Lukolis, Khunyangu
        • physical_addressWestern Kenya
        • contact_detailsBox 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2019-06-05 09:03:56
        • modified2020-03-13 10:09:42
        • County(array)
          • id40
          • county_nameBusia
          • created2012-06-15 10:26:51
          • modified2012-06-15 10:26:51
      • 2(array)
        • id660
        • application_id801
        • county_id37
        • site_name Mumias
        • physical_addressWestern Kenya
        • contact_detailsBox 4606 30100 Eldoret, Kenya.0733 788 063 and 0733 836 410
        • contact_personDr. Paul Nyongesa and Prof Fabian Esamai
        • site_capacity(null)
        • misc(null)
        • created2019-06-05 09:03:56
        • modified2020-03-13 10:09:42
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
    • Sponsor(array)
      • 0(array)
        • id391
        • application_id801
        • sponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
        • sponsor_typeOthers
        • contact_personMenachem Miodovnik, MD
        • addressNational Institutes of Health 6100 Executive Blvd, Rm 4B03A Bethesda, MD 20892-7510
        • telephone_number): 301-451-5031
        • fax_number: 301-496-3790
        • cell_number): 301-451-5031
        • email_addressMenachem.Miodovnik@nih.gov
        • created2019-06-05 08:13:20
        • modified2020-03-13 10:09:42
  • 3(array)
    • Application(array)
      • id519
      • user_id38
      • trial_status_id4
      • abstract_of_study<p>\n Great public health benefits are gained by targeting the sexual forms of <em>Plasmodium falciparum</em>, – the gametocytes – since this is the form of the parasite that gets transmitted to other susceptible hosts via the mosquito. While Artemisinin-based Combination Therapies (ACTs) do have some gametocytocidal activity, only the 8-aminoquinoline (8-AQ) class of anti-malarial compounds (such as primaquine) have demonstrated the ability to target the key form of gametocyte that eventually gets transmitted – the stage V. The efficacy of primaquine is dependent on the ability of the human body to metabolize the drug into its active metabolites, a process that is thought to be mediated by the cytochrome P450 system. Unfortunately, the use of 8-AQs is limited by their tendency to cause haemolytic anaemia in individuals with a genetic deficiency in glucose-6- phosphate dehydrogenase (G6PD). This study proposes to estimate the prevalence of G6PD deficiency and also to study primaquine metabolism and its association with the alleles of the CYP2D6 and CYP2C19 genes among the population of Seme and Kisumu West sub-counties of Kisumu county, western Kenya.  The findings of the study will likely influence policy regarding the use of primaquine within the region.</p>\n<p>\n                                                                                </p>\n
      • study_title<p>\n Primaquine metabolism and its association with CYP2D6 and CYP2C19 genotypes among adults living within Seme and Kisumu West sub-counties of Kisumu County, Western Kenya</p>\n<p>\n  </p>\n
      • laymans_summary(null)
      • short_titleCYP STUDY
      • protocol_noECCT/16/07/03
      • version_noVersion 3.7
      • date_of_protocol12-07-2015
      • study_drugPRIMAQUINE
      • disease_conditionMALARIA
      • 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_namePRIMAQUINE
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvowira@clinicalrmafrica.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicant+254722430933
      • declaration_date112-07-2016
      • declaration_principal_investigatorDR BEN ANDAGALU
      • declaration_date212-07-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <u>Inclusion criteria</u></p>\n<ul>\n <li>\n Adults  aged 18 years and above residing within the study area, and in good general health.</li>\n <li>\n Ability and willingness to provide consent / Potential subjects who are illiterate  will be offered the opportunity to select an independent witness</li>\n <li>\n Availability for the duration of the study and willingness comply with the study procedures</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <u>Exclusion criteria for CYP/G6PD testing</u></p>\n<ul>\n <li>\n Conditions that, in the opinion of the investigator, will result in an adverse outcome should the potential subject participate in the study</li>\n</ul>\n<p style=\"margin-left: 0.5in;\">\n  </p>\n<p style=\"margin-left: 0.5in;\">\n <u>Exclusion criteria for primaquine administration</u></p>\n<ul>\n <li>\n G6PD deficiency</li>\n <li>\n Pregnant or lactating females</li>\n <li>\n History of allergy to primaquine</li>\n <li>\n Family history of favism, hemolytic anemia or nicotinamide adenine dinucleotide methemoglobin reductase deficiency</li>\n <li>\n Hematocrit of less than 30%</li>\n <li>\n Recent use of quinacrine</li>\n <li>\n Concurrent use of other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow</li>\n <li>\n Presence of systemic diseases such as rheumatoid arthritis or lupus erythematosus (from medical history)</li>\n</ul>\n
      • primary_end_points<p style=\"margin-left: 0.5in;\">\n Correlation between CYP2D6 and CYP2C19 genotypes and primaquine metabolism among adults living within Seme and Kisumu West sub-counties of Kisumu county, Western Kenya.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPharmacogenetic trial
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The site has relevant infrastructure to run this study, these include senior researchers/Investigators, associate investigators, Clinical Research Coordinators (CRCs). The site has a dedicated CRC, Clinical laboratory, Research pharmacy, emergency rooms well equiped with emergency kits and manned by staff trained on handling emergencies including anaphylactic reaction.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n NONE</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</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_areaKOMBEWA CLINICAL RESEARCH CENTRE
      • single_site_physical_addressALONG KISUMU BONDO ROAD OPPOSITE KOMBEWA SUB COUNTY HOSPITAL
      • single_site_contact_personDR BEN ANDAGALU
      • single_site_telephone+254716004851
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site422
      • total_participants_worldwide422
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_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_nameBEN
      • investigator1_middle_name
      • investigator1_family_nameANDAGALU
      • investigator1_qualificationMD MSC (CLINICAL TRIALS)
      • investigator1_professional_addressP.O BOX 54, 40100 KISUMU
      • investigator1_telephone+2454716004851
      • investigator1_emailben.andagalu@usamru-k.org
      • organisations_transferred_No
      • number_participants422
      • notification
      • approval_date05-05-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-10-2016
      • 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)
      • modified2018-03-19 17:12:23
      • created2016-07-12 13:08:06
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id340
        • application_id519
        • given_nameBEN
        • middle_name
        • family_nameANDAGALU
        • qualificationMD MSC (CLINICAL TRIALS)
        • professional_addressP.O BOX 54, 40100 KISUMU
        • telephone+2454716004851
        • emailben.andagalu@usamru-k.org
        • created2016-07-12 15:11:36
        • modified2016-10-11 16:42:54
      • 1(array)
        • id341
        • application_id519
        • given_nameBEN
        • middle_name
        • family_nameANDAGALU
        • qualificationMD MSC (CLINICAL TRIALS)
        • professional_addressP.O BOX 54, 40100 KISUMU
        • telephone+2454716004851
        • emailben.andagalu@usamru-k.org
        • created2016-07-12 15:17:23
        • modified2016-10-11 16:42:54
    • SiteDetail(array)
      • 0(array)
        • id404
        • application_id519
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-07-12 15:11:36
        • modified2016-10-11 16:42:54
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id271
        • application_id519
        • sponsorUNITED STATES MEDICAL ARMY RESEARCH UNIT, KENYA
        • sponsor_type(null)
        • contact_person
        • addressP. O BOX 54, 40100 KISUMU
        • telephone_number0733333530
        • fax_number
        • cell_number0733333530
        • email_addressadmin@usamru-k.org
        • created2016-07-12 15:11:36
        • modified2016-10-11 16:42:54
  • 4(array)
    • Application(array)
      • id969
      • user_id622
      • trial_status_id5
      • abstract_of_study<p dir=\"ltr\" style=\"line-height:1.2;margin-left: -21.3pt;margin-top:0pt;margin-bottom:0pt;\">\n <span id=\"docs-internal-guid-c33dbd95-7fff-2f0b-bfc5-ca5cb9ed2a5d\"><span style=\"font-size: 11pt; font-family: Arial; color: rgb(0, 0, 0); background-color: transparent; font-weight: 700; font-variant-numeric: normal; font-variant-east-asian: normal; vertical-align: baseline; white-space: pre-wrap;\">S</span></span><strong>SStudy Title:</strong> Prospective No-Interventional Multi-Center Study Evaluating Bleeding Incidence and Health-Related Quality of Life in Patients with Hemophilia A with Inhibitors and Non-Inhibitors Treated with Emicizumab and other Hemophilia A Treatments in a real-Life Setting.    </p>\n<p>\n  </p>\n<p>\n <strong>Name of Principal Investigator</strong>: Festus Njuguna, MD </p>\n<p>\n     </p>\n<p>\n  </p>\n<p>\n <strong>Co-investigators: </strong>Carole Kilach, MD  </p>\n<p>\n  </p>\n<p>\n <strong>Supervisors: </strong>Cyrus Njuguna, Gabriel Omwalo, Huwaida Bulhan</p>\n<p>\n  </p>\n<p>\n <strong>Name of Organization:</strong> AMPATH/MTRH</p>\n<p>\n  </p>\n<p>\n <strong>Funding:</strong> ROCHE Pharmaceuticals</p>\n<p>\n  </p>\n<p>\n <strong>Broad Objectives: </strong>To analyze all treated bleeds as measured by annualized bleeding rate (ABR) in hemophilia A patients according to treatment type within two patients’ groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice. </p>\n<p>\n  </p>\n<p>\n <strong>Specific Objectives:</strong></p>\n<ul>\n <li>\n To analyze the difference in number of all treated bleeds in Hemophilia A patients before and after receiving emicizumab (intra-patient analysis). This analysis will only apply for the patients who are switched to emicizumab at least 6 months after study entry. </li>\n <li>\n To analyze the number of all bleeds (treated and not treated), including joint bleeds, major bleeds, traumatic and spontaneous bleeds, in Hemophilia A patients within two patients’ groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice. </li>\n <li>\n To analyze the percentage of patients with zero bleeding rate. </li>\n <li>\n To collect information on safety in Hemophilia A patients within two patients’ groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice. </li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Study setting: </strong>Hemophilia Clinic in Moi Teaching and Referral Hospital</p>\n<p>\n  </p>\n<p>\n <strong>Study population: </strong>Patients with congenital Severe Hemophilia A with or without inhibitors under treatment with Emicizumab and other hemophilia A treatment options.  </p>\n<p>\n  </p>\n<p>\n <strong>Number of subjects to be contacted</strong>: In Kenya, 20 participants will be recruited from MTRH as the only participating site nationally. Globally, approximately 705 participants will be recruited. </p>\n<p>\n  </p>\n<p>\n <strong>Study procedures (main) done on participants: </strong></p>\n<p>\n <br />\n  </p>\n<ul>\n <li>\n Blood specimens drawn: N/A</li>\n</ul>\n<p>\n <br />\n  </p>\n<ul>\n <li>\n Surgical procedure: N/A</li>\n</ul>\n<p>\n <br />\n  </p>\n<ul>\n <li>\n Questionnaires: Yes</li>\n</ul>\n<p>\n <br />\n  </p>\n<ul>\n <li>\n FGDs:  N/A</li>\n</ul>\n<p>\n <br />\n  </p>\n<ul>\n <li>\n Informed consent: Written </li>\n</ul>\n
      • study_title<p>\n PROSPECTIVE NON-INTERVENTIONAL MULTI-CENTER STUDY EVALUATING BLEEDING INCIDENCE AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH HEMOPHILIA A WITH INHIBITORS AND NON-INHIBITORS TREATED WITH EMICIZUMAB AND OTHER HEMOPHILIA TREATMENTS IN A REAL-LIFE SETTING</p>\n
      • laymans_summary<p>\n This a Non-interventional study in Real world setting. The study will evaluate bleeding incidence and quality of life for Hemophilia A (with or without inhibitors) patient receiving hemophilia treatment.</p>\n<p>\n The main objective is to analyze the treated bleeds according to the treatment the hemophilia A patient received within two patients groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice.</p>\n<p>\n Observation over all patients will last for 1 year (52 weeks) from their first data collection. If the patient has changed his treatment regimen within the initial 52 weeks observation period, additional 1 year (52 weeks) of observation will be added.</p>\n<p>\n Patients will collect detailed information about any bleeding event (date and start time of bleeding, location of bleeding, type of bleeding) via a Bleeds & Medication Questionnaire (BMQ), which will be installed on smart devices provided by the Sponsor. Paper based EQ-5D-5L questionnaire will be collected approximately each 3 months (13 weeks). Other data will be collected from the patients’ clinical notes.</p>\n<p>\n The study will be conducted at approximately 80 sites in approximately 25 countries. Approximately 705 patients will be included (609 patients with no inhibitors against FVIII; 96 patients with inhibitors).</p>\n<p>\n  </p>\n
      • short_titleRESHAPE
      • protocol_noECCT/21/02/02
      • version_no1
      • date_of_protocol15-04-2020
      • study_drugNot Applicable - Non-interventional Study
      • disease_conditionHemophilia A
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameNot Applicable
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresshuwaida.bulhan@roche.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGilbert Ogetii
      • declaration_date102-02-2021
      • declaration_principal_investigatorFestus Njuguna
      • declaration_date229-01-2021
      • placebo_presentNo
      • study_objectives<p>\n <strong>Effectiveness Objectives </strong></p>\n<p>\n The primary effectiveness objective for this study is as follows:</p>\n<ul>\n <li>\n To analyze all treated bleeds as measured by annualized bleeding rate (ABR) in hemophilia A patients according to treatment type within two patients groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice.</li>\n</ul>\n<p>\n The secondary effectiveness objectives for this study are as follows:</p>\n<ul>\n <li>\n To analyze the difference in number of all treated bleeds in hemophilia A patients before and after receiving emicizumab (intra-patient analysis). This analysis will only apply for the patients who are switched to emicizumab at least 6 months after study entry.</li>\n <li>\n To analyze the number of all bleeds (treated and not treated), including joint bleeds, major bleeds, traumatic and spontaneous bleeds, in HA patients within two patients groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice.</li>\n <li>\n To analyze the percentage of patients with zero bleeding rate.</li>\n</ul>\n<p>\n <strong>Safety Objectives</strong></p>\n<p>\n The safety objectives for this study are as follows:</p>\n<ul>\n <li>\n To collect information on safety in HA patients within two patients groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice.</li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n ● Patients with congenital HA.</p>\n<p>\n ● Patients with severe disease (severity classified based on percentage FVIII activity level in the blood as severe < 1%).</p>\n<p>\n ● Signed informed consent must be obtained from parent/legally acceptable representative and an assent from the child when applicable (latest approved version by the Independent Ethics Committee [IEC]/Institutional Review Board [IRB]) prior to any of the study-specific assessments and procedures being performed.</p>\n<p>\n ● Treated in one of the participating centers 26 weeks in a stable regimen before inclusion to the study.</p>\n<p>\n ● Patients receiving treatment for HA with recombinant activated human FVIIa and/or activated prothrombin complex concentrate, plasma-derived/recombinant FVIII or emicizumab according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to emicizumab (Hemlibra).</p>\n
      • principal_exclusion_criteria<ul>\n <li>\n Patients not receiving treatment for HA with any of listed in the protocol studied medications according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.</li>\n <li>\n A primary diagnosis or co-inheritance of Hemophilia B, Von Willebrand’s disease, other hemostatic deficiencies.</li>\n <li>\n Renal / liver impairment.</li>\n <li>\n Thrombotic microangiopathy/thromboembolism in medical history.</li>\n <li>\n Planned ITI during participation in the study</li>\n <li>\n Informed consent not obtained.</li>\n <li>\n Patients with acquired HA.</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n Primary endpoint:</p>\n<ul>\n <li>\n All treated bleeds as measured by annualized bleeding rate (ABR). The primary definition of a treated bleed is a bleed for which coagulation factors are administered.</li>\n</ul>\n<p>\n Other endpoints:</p>\n<ul>\n <li>\n Inhibitors status (positive or negative) and its titre (Bethesda units) of HA patients before and during the study.</li>\n <li>\n Patient’s treatment at the time of study entry and its changes (if any) during the study.</li>\n <li>\n Patient’s number of target joints at the time of study entry and at the end of the study</li>\n</ul>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyReal-world practice treatment\nQuality of life (QOL)
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyNon-Interventional Study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n PI - Dr Festus Njuguna - MBChB; M.Med(Pead.& Child Health). Dr Njuguna is currently the Head, Paediatric haemato-oncology unit, Moi Teaching and Referral Hospital. Investigator has extensive previous research experience with publications. Currently has 3 ongoing studies. Study team would consist of team members from the Hematology department and sufficient resources are available within the Hematology department. </p>\n<p>\n Sub-Investigator - Dr Carole Jesang Kilach - Dr Kilach is a Medical Officer in the Hemato-Oncology department of Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.</p>\n<p>\n Cyrus Njuguna - Study Coordinator</p>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n Hemophilia clinica is located in Chandaria Cancer and Chronic Disease Management Centre (CCCDMC) in MTRH. </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n It's part of the hematology department in the larger Hemato-Oncology directorate. </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n  </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n The clinic covers all hematological conditions both malignant and non-malignant and has a total of 230 hemophilia patients.  </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n It is covered by 10 nurses, 1 medical officer who is a full time, a pediatrician, a hematologist, a lab scientist, a lab technician, 2 pharm-techs, 2 psychological counselors, and a physiotherapist. </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n  </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n It has a functional lab able to test both factor and inhibitor assays and a pharmacy that's is well covered to provide access to medications(Factor products only when available) all through.  </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n  </div>\n<div style=\"font-family: Arial, Helvetica, sans-serif; font-size: small;\">\n The physiotherapist is provided with a portable ultrasound machine for joint and muscle bleeds assessment</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not Applicable - Roche Kenya Ltd is the sponsor </p>\n
      • other_details_regulatory_notapproved<p>\n RA review and approval is in progress for the following countries: Algeria, Belarus, Bosnia & Herzegovina, Dominican Republic, Mexico, Paraguay, Saudi Arabia and United Arab Emirates.</p>\n
      • other_details_regulatory_approved<p>\n Note: Not all countries participating in this non-interventional study require RA submission and approval.</p>\n<p>\n The protocol have been approved by the regulatory authorities in the following countries:</p>\n<p>\n Colombia - 28-Aug-2020</p>\n<p>\n Egypt - 02-Sep-2020</p>\n<p>\n Peru - 25-Sep-2020</p>\n<p>\n Russia - 13-Aug-2020</p>\n<p>\n Turkey - 21-Jan-2021</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable - None</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable - None</p>\n
      • estimated_durationThis study will last approximately 4 years (208 weeks) from the start date of study. Enrollment for the patients to the study will last for approximately 2 years (104 weeks).
      • 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_areaMoi Teaching and Referral Hospital
      • single_site_physical_addressChandaria Cancer and Chronic Disease Management Centre, Nandi Road, Eldoret, Kenya
      • single_site_contact_personCyrus Njuguna
      • single_site_telephone+254710119102
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_statesapproximately 25 Countries - Additional countries/sites may be added depending on the overall study recruitment rate
      • number_of_sites
      • multi_country_listAlbania, Algeria, Argentina, Belarus, Bosnia and Herzegovina, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, Georgia, Greece, Iran, Kazakhstan, Kenya, Mexico, Panama, Paraguay, Peru, Philippines, Russian Federation, Saudi Arabia, Serbia, Sudan, Turkey, United Arab Emirates, Uruguay.
      • data_monitoring_committeeNo
      • total_enrolment_per_site20
      • total_participants_worldwide705
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • 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_specifyPersons below 18 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNot Applicable - Only one site in Kenya
      • investigator1_middle_name
      • investigator1_family_nameNot Applicable - Only one site in Kenya
      • investigator1_qualificationNot Applicable - Only one site in Kenya
      • investigator1_professional_addressNot Applicable - Only one site in Kenya
      • investigator1_telephoneNot Applicable - Only one site in Kenya
      • investigator1_emailMuigaifes2000@gmail.com
      • organisations_transferred_Yes
      • number_participants20
      • notification<p>\n The submitted study is non-interventional, therefore, documentation related to IMP will not be applicable and file notes have been filled to provide explanation.</p>\n<p>\n Fields related to IMP and pharmacist have been completed with dummy data to advance the completion of this form even though these are not applicable because there is no IMP for this study.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • approval_date12-05-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-02-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved
      • final_report<p>\n The primary objective of the study was to analyze all treated bleeds as measured by ABR in patients with hemophilia A according to treatment type within two patients groups (Cohort A: patients without FVIII inhibitors and Cohort B: patients with FVIII inhibitors) under routine clinical practice and to estimate the number of bleeds over time.</p>\n<p>\n With respect to effectiveness outcomes:</p>\n<p>\n ● In Cohort A, the proportion of patients in the CAP with zero treated bleeds during their observation period from enrollment to end of study (or treatment regimen switching, if any) was 77.8% for emicizumab,10.8% for FVIII – on demand, and 34.8% for FVIII – prophylaxis. The respective mean calculated ABRs were 0.3 (0.00; 4.31), 12.2 (6.37; 21.27), and 4.3 (1.22; 10.62). The corresponding model based ABRs (95% CI) were 0.5 (0.25; 0.97), 8.5 {(6.24; 11.59), and 5.7 (4.80; 6.79), respectively. The upper level of the model based CI for emicizumab was lower than the lower tail of the model based CI for FVIII – on demand and for FVIII – prophylaxis.</p>\n<p>\n ● In Cohort B, the proportions of patients in the CAP with zero treated bleeds during their observation period from enrollment to end of study (or treatment regimen switching, if any) were 81.5% for emicizumab, 10.4% for BPA – on demand, and 31.4% for BPA – prophylaxis. The respective mean calculated ABRs were 0.6 (0.00; 4.85), 10.3 (5.00; 18.77), and 8.3 (3.65; 16.15). The corresponding model based ABRs (95% CI) were 0.9 (0.54; 1.41), 9.5 (6.50; 13.78), and 7.8 (5.28; 11.61), respectively. The upper level of the model based CI for emicizumab was lower than the lower tail of the model based CI for BPA – on demand and for BPA – prophylaxis.</p>\n<p>\n ● Subgroup analyses by age (years) at baseline (<18, ≥18), age (years) at baseline (<12, [12-18[, ≥18), number of bleeds during 26 weeks prior to study entry (<6, ≥6), number of target joints at baseline (no target joint, any target joint), and region showed results similar to those observed in the primary analysis of treated bleeds.</p>\n<p>\n ● The intra-patient analysis of patients who switched to emicizumab during the study showed a mean calculated ABR for treated bleed of 5.1 (1.69; 11.84) before switching and 0.0 (NA; 3.69) after switching for the combination FVIII prophylaxis – emicizumab; 10.0 (4.82; 18.44) before switching and 0.4 (0.00; 4.45) after switching for the combination BPA on demand – emicizumab, and 5.5 (1.90; 12.34) before switching and 9.4 (4.36; 17.56) after switching for the combination BPA – prophylaxis to emicizumab. The differences between emicizumab and FVIII/BPA prophylaxis were not estimable</p>\n<p>\n ● When considering all bleeds (treated or not treated), the proportion of patients in the CAP with zero bleeds during their observation period from enrollment to end of study (or treatment regimen switching, if any) was:</p>\n<ul>\n <li>\n Cohort A: 53.3% in the emicizumab group, 5.4% in the FVIII – on demand group, and 18.8% in the FVIII – prophylaxis group. The respective mean calculated ABR (95% CI) were 2.3 (1.50; 3.43), 13.0 (10.06; 16.82), and 9.3 (8.10; 10.79).</li>\n <li>\n Cohort B: 55.6% in the emicizumab group, 6.3% in the BPA – on demand group, and 13.7% in the BPA – prophylaxis group. The respective mean calculated ABR (95% CI) were 1.9 (0.21; 7.04), 15.6 (8.86; 25.51), and 11.6 (5.91; 20.43).</li>\n</ul>\n<p>\n ● When analyzing data by type of bleed, a higher proportion of patients with zero bleeds from enrollment to end of study (or treatment regimen switching, if any) was consistently observed in the emicizumab group compared with the ondemand and prophylaxis groups in both cohorts for the following categories of bleed: spontaneous treated bleeds, spontaneous bleeds, traumatic treated bleeds, traumatic bleeds, target joint treated bleeds, target joint bleeds, joint treated bleeds, and joint bleeds. For major treated bleeds, all major bleeds, treated bleeds related to procedure/surgery, and bleeds related to procedure/surgery, similar high proportion of patients with zero bleeds were observed across all groups – these types of bleeds were essentially very rare in all treatment groups</p>\n<p>\n ● The proportions of patients in the CAP with zero bleeds (all bleeds) during their observation period from enrollment to end of study (or treatment regimen switching, if any) were:</p>\n<ul>\n <li>\n Cohort A: 53.3% for emicizumab, 5.4% for FVIII – on demand, and 18.8% for FVIII – prophylaxis (50.0%, 4.2%, and 17.8%, respectively, in the subset of CAP with at least 26 weeks of observation).</li>\n <li>\n Cohort B: 55.6% for emicizumab, 6.3% for BPA – on demand, and 13.7% for BPA – prophylaxis (55.7%, 7.1%, and 10.8%, respectively, in the subset of CAP with at least 26 weeks of observation).</li>\n</ul>\n<p>\n With respect to safety:</p>\n<p>\n ● In both cohorts, the percentage of patients reporting at least 1 TEAE was similar across the 3 groups: 28.8% for emicizumab, 29.9% for FVIII – on demand, and 33.2% for FVIII - prophylaxis in Cohort A and 31.7% for emicizumab, 31.4% for BPA – on demand, and 31.6% for BPA – prophylaxis in Cohort B.</p>\n<p>\n ● No TEAEs led to treatment discontinuation.</p>\n<p>\n ● Related TEAEs were reported by a low number of patients, with only 2 patients (3.0%) in Cohort A and 4 patients (3.8%) in Cohort B reporting TEAEs related to emicizumab.</p>\n<p>\n ● The frequency of SAEs was low and similar across all groups in Cohort A (3.0% for emicizumab, 3.9% for FVIII – on demand, and 6.4% for FVIII – prophylaxis). In Cohort B, the frequency was numerically higher for BPA – on demand (11.8%) and BPA – prophylaxis (8.8%) compared with emicizumab (3.8%). For both cohorts, there were no specific pattern in the reporting of SAEs, with SAEs reported across different SOCs. At the PT level, there were no SAE reported in >1 patient in a group, except for haematuria, haematemesis, and haemarthrosis.</p>\n<p>\n ● Grade 3 or 4 TEAEs were reported by 4.5% of patients for emicizumab, 5.2% for FVIII – on demand, and 6.1% for FVIII - prophylaxis (Cohort A) and by 3.8% of patients for emicizumab, 13.7% for BPA – on demand, and 8.8% for BPA – prophylaxis (Cohort B). ● Two deaths were reported during the study, both in FVIII – prophylaxis group (Cohort A) and both considered not related to treatment.</p>\n<p>\n ● Four patients in Cohort A and one patient in Cohort B reported at least one AESI; no AESIs were reported in patients treated with emicizumab.</p>\n
      • implication_results<p>\n In this study, considerable differences were seen in the use of prophylactic treatment in patients with or without inhibitors. Approximately 15% of patients without inhibitors against FVIII (Cohort A) were found to be on-demand versus approximately 26% for those with inhibitors against FVIII (Cohort B). Among patients treated with prophylactic regimens, a much higher proportion of patients was found to be on emicizumab among patients with inhibitors (45%) compared to those without inhibitors (9.2%) across the study cohorts.</p>\n<p>\n Despite the observational nature of the study, consistent findings of lower ABR were noted among patients treated with prophylactic treatments versus patients treated on demand. Furthermore, prophylactic treatment with emicizumab was observed to have consistently lower ABR compared with prophylactic treatment using FVIII or BPA. These findings suggest that bleeding-related disease burden could be substantially reduced in these settings by the use of prophylactic treatment regimens, and a particularly meaningful bleeding-related disease burden reduction may be achieved by the use of emicizumab.</p>\n<p>\n The same pattern was noted in other aspects, such as economic/healthcare utilization. Patients receiving prophylactic treatment with emicizumab appeared to have consistently lower number of days away from school/university/work, lower number of days in hospital, and lower number of days with healthcare utilization compared with prophylactic treatment using FVIII or BPA.</p>\n<p>\n The treatment regimens used by the patients in this study showed a good safety profile. There were no deaths in patients treated with emicizumab. There were TEAEs leading to treatment discontinuation reported during the study. Very few patients switched treatment after starting emicizumab. Among patients treated with emicizumab, no adverse events of special interest and no TEAEs of thrombotic microangiopathy or thromboembolism were reported in patients treated with emicizumab</p>\n
      • quantity_importedN/A
      • quantity_dispensedN/A
      • quantity_destroyedN/A
      • quantity_exportedN/A
      • balance_siteN/A
      • final_date0000-00-00
      • modified2025-02-26 09:56:05
      • created2021-01-25 09:03:13
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id614
        • application_id969
        • given_nameFestus
        • middle_name
        • family_nameNjuguna
        • qualificationMBChB; M.Med(Pead.& Child Health)
        • professional_addressMoi University College of Health Sciences, P.O Box 4606-30100
        • telephone+254-721-219761
        • emailMuigaifes2000@gmail.com
        • created2021-01-25 13:50:24
        • modified2021-02-04 11:16:26
    • SiteDetail(array)
      • 0(array)
        • id852
        • application_id969
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-01-25 13:50:24
        • modified2021-02-04 11:16:26
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id477
        • application_id969
        • sponsorRoche Kenya Ltd
        • sponsor_typeIndustry
        • contact_personGilbert Ogetii
        • addressThe Atrium 6th Floor, Chaka Road off Lenana Road P.O. Box 44212-00100
        • telephone_number+254780441913
        • fax_number
        • cell_number+254780441913
        • email_addresskenya.clinicaltrialske@roche.com
        • created2021-01-25 13:50:24
        • modified2021-02-04 11:16:26
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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