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    • Application(array)
      • id409
      • user_id73
      • trial_status_id5
      • abstract_of_study<p style=\"text-align: justify;\">\n Our objective is to study effects of a contraceptive vaginal ring (CVR) containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local immunity in women. We will build on data that support a favorable effect of CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in <u>></u>50% of women in sub-Saharan Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male partners. Pregnancy is also an independent risk for HIV acquisition and transmission. Contraception comprises critical biomedical prevention for women with or at risk for HIV. Systemic depot progesterone—commonly used throughout Africa—may independently increase risk of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy and promoting a protective vaginal microenvironment could synergistically reduce HIV risk especially combined with topical antiretrovirals (ARV). We hypothesize NuvaRing use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV shedding in HIV-infected women. <u>Sustained vaginal delivery of contraceptive and ARV PrEP as “multicomponent prevention” is a major focus for scientists but effects on the vaginal environment need careful definition before broad implementation</u>.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 1: Determine effect of CVR on vaginal bacteria, including incident/persistent BV. </strong>Show whether sustained local hormone delivery promotes desirable lactobacilli, and thus reduces risk of BV, in women with and without HIV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 2. Define the soluble mucosal host immune response and endocervical immune cell populations with CVR. </strong>Determine if shifts in vaginal bacteria anticipated to occur with CVR will be accompanied by favorable changes in the lower genital tract, including restoration of protective mediators decreased with BV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 3. In HIV-infected women, determine effect of CVR on genital HIV shedding. </strong>HIV-infected women not on ART at enrollment will have endocervical swabs collected for HIV RNA quantification.</p>\n<p style=\"text-align: justify;\">\n <strong>Study Site and Population</strong></p>\n<p style=\"text-align: justify;\">\n This study will be conducted at the Thika Partners Study Clinic located in Thika, Kenya. We will enroll approximately 120 women with bacterial vaginosis (BV) based on clinical criteria and a minimum of 75 male sex partners.</p>\n
      • study_title<p align=\"center\">\n <strong>Effects of contraceptive ring on vaginal microbiota, HIV shedding and local immunity</strong></p>\n
      • laymans_summary<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.<a href=\"#_ENREF_1\" title=\"Polis, 2013 #1991\">¹</a> Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<a href=\"#_ENREF_2\" title=\"van der Straten, 2012 #3050\">²</a> A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<a href=\"#_ENREF_3\" title=\"Kiser, 2012 #3052\">³</a> Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n<p>\n  </p>\n
      • short_titleNuvaRing Study
      • protocol_noECCT/15/09/01
      • version_no2.4
      • date_of_protocol23-06-2015
      • study_drugNuvaRing (Vaginal contraceptive ring)
      • disease_conditionVaginal Bacteria, HIV & Vaginal local Immunity
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameEstrogen & Progesterone
      • product_type_medical_device_nameContraceptive Vaginal Ring (NuvaRing)
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
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      • applicant_fees1
      • applicant_complete_form(null)
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      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Kenneth Ngure
      • declaration_date102-09-2015
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date202-09-2015
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective:</strong></p>\n<p>\n To assess potential benefits associated with both cyclic (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women (both HIV-negative and HIV-positive) with BV at enrollment (and thus at high risk for BV persistence and recurrence).</p>\n<p>\n <strong>Secondary objectives: </strong></p>\n<ol style=\"list-style-type:lower-roman;\">\n <li>\n To determine the effect of the CVR on clinically defined incidence of BV, the vaginal microbiome and rates of adverse events with CVR use.</li>\n <li>\n To assess the acceptability of the CVR to men who are sex partners of study participants.</li>\n <li>\n To assess acceptability and preference for contraceptive type at study end.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong>Female Eligibility Criteria:</strong></p>\n<ul>\n <li>\n ≥18-40 year old BV+ by Amsel’s criteria</li>\n <li>\n Not intending or wishing to become pregnant over the course of the study</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n<div>\n  </div>\n<p>\n <strong>Male Eligibility Criteria:</strong></p>\n<ul>\n <li>\n Main sex partner of randomized female participant</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong>Female Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Current pregnancy</li>\n <li>\n Desire/intent to become pregnant over the course of the study</li>\n <li>\n Current cigarette smoking if age is older than 35 years</li>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n<p>\n <strong>Male Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n
      • primary_end_points<p style=\"margin-left:.5in;\">\n Outcome 1:  Quantity of <em>L. crispatus</em> determined by species-specific qPCR assay</p>\n<p style=\"margin-left:.5in;\">\n Outcome 2:  Local immune parameters, including cytokines, innate mediators, and functional antimicrobial activity in cervicovaginal secretions as assessed                        by anti-<em>E. coli</em>, anti-HSV, and anti-HIV activity</p>\n<p style=\"margin-left:.5in;\">\n Outcome 3:  Quantity of genital HIV shedding among HIV-infected participants </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Elizabeth Irungu  MBChB</p>\n
      • other_details_explanation<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<span style=\"font-size: 10px;\"> </span>A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<span style=\"font-size: 10px;\"> </span>Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Washington Institutional Review Board (UW IRB)</p>\n<p>\n Submission will be done before end of September 2015</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute's (KEMRI) Scientific, Ethics and Research Unit (SERU)</p>\n<p>\n                     Approved on 20th July 2015.</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_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_areaThika Partners Study Clinic (Partners in Health Research and Development) affiliated to the University of Washington International Clinical Research Center (ICRC), and KEMRI
      • single_site_physical_addressOAU Road, Near Thika Nursing Home
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067-2222561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site195
      • total_participants_worldwide195
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_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_nameJeanne
      • investigator1_middle_name
      • investigator1_family_nameMarrazzo
      • investigator1_qualificationProfessor of Medicine
      • investigator1_professional_addressUniversity of Washington, Seattle
      • investigator1_telephone+1-206-744-3679
      • investigator1_emailjmm2@u.washington.edu
      • organisations_transferred_Yes
      • number_participants120 women with bacterial vaginosis (BV) and a minimum of 75 male sex partners.
      • notification
      • approval_date16-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
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      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-15 11:42:25
      • created2015-07-28 16:22:20
      • total_sites(null)
      • ecitizen_invoice(null)
      • ai_content(null)
    • InvestigatorContact(array)
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        • id279
        • application_id409
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • investigator_roleprincipal
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
    • SiteDetail(array)
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        • application_id409
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        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
        • County(empty)
    • Sponsor(array)
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        • id217
        • application_id409
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067 22561
        • fax_numbern/a
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
  • 1(array)
    • Application(array)
      • id1566
      • user_id294
      • trial_status_id2
      • abstract_of_study<p>\n Preterm and small for gestational age (SGA) infants have a 2- to 10-fold higher risk of mortality than infants born at term and with normal birth weight, and are particularly vulnerable to infection, malabsorption, necrotizing enterocolitis, difficulty feeding, and growth failure. Numerous trials conducted in the last ten years have reported that probiotics can improve short- and long-term mortality, necrotizing enterocolitis and sepsis rates, and growth and neurodevelopment in preterm and low birth weight infants. However, most trials have been small and with high to moderate risk of bias. There have been no trials in SGA infants. The World Health Organization (WHO) guideline development group (GDG) and other organizations have recommended that further large high-quality trials are implemented to provide evidence of sufficient quality and applicability to inform policy and practice. The overall aim of this trial is to assess the effect of probiotic supplementation on mortality, morbidity, and growth in preterm or term SGA infants in the first 6 months of life in South Asia and Sub-Saharan Africa. The trial is a multi-country multi-centre individually-randomised double-blind parallel-group placebo-controlled superiority trial implemented in five countries: two in Asia (Bangladesh, Pakistan) and three in Africa (Ethiopia, Nigeria, Kenya). A total of 14,000 (2900 in Kenya) eligible infants will be enrolled across the 5 participating countries and randomly assigned to either the intervention or control group separately for the preterm and term SGA infants. Each randomized infant will receive the study supplements (probiotics or placebo) daily for 28 days and followed up monthly for primary and secondary outcome endpoint assessment by an independent outcome assessment team until the infant reaches 6 months of age. Endpoint data will also be collected on all infants admitted to study hospitals. Results from this trial will help inform policy and practice for probiotic supplementation in preterm and SGA infants, improve the certainty of evidence on critical outcomes and strengthen the understanding of optimal strains, dosing and duration of probiotic supplementation and related impact in high burden LMICs.</p>\n
      • study_title<p align=\"center\">\n <strong>Efficacy of probiotic supplementation in preterm and small for gestational age infants. A multi-centre, placebo-controlled, individually-randomised trial</strong></p>\n
      • laymans_summary<p>\n <strong>What is the problem?</strong></p>\n<p>\n Babies born before their due date for delivery(preterm) and babies born small for gestational age (SGA) infants have 2-10 times higher risk of death than infants born at term and with normal birth weight, and are particularly vulnerable to infection, malabsorption, severe bowel infection, difficulty feeding, and growth failure. Improvements in outcomes in preterm and SGA infants have been slow in all countries, especially low- and middle- income countries (LMICs), due to the complexities of preventing complications and providing medical care for small and vulnerable infants.</p>\n<p>\n <strong>What question are we trying to answer?</strong></p>\n<p>\n We aim to test the effect of probiotic supplementation on death, diseases, and growth in preterm or term SGA infants in the first 6 months of life in South Asia and Sub-Saharan Africa.</p>\n<p>\n <strong>Where is the study taking place? </strong></p>\n<p>\n The study will be conducted in four hospitals in Kenya namely; Migori County Referral Hospital, Homabay County Referral Hospital, Kisii Teaching and Referral Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital. Recruitment may also take place at St. Joseph’s Mission Hospital and Kendu Bay Mission Hospital. Other participating countries include Bangladesh, Pakistan, Ethiopia and Nigeria.</p>\n<p>\n <strong>How many people does it involve and how are they selected?</strong></p>\n<p>\n The study will enroll 2,900 eligible infants in Kenya (14,000 across the 5 participating countries). Eligible infants include preterm (AGA or SGA) or term SGA infants, aged less than 48 hours at the time of enrollment and likely to be in the study area for the next 6 months. Infants who are less than 28 weeks gestation, not able to take orall feeds, confirmed blood stream infection at the time of enrolment, indwelling umbilical catheter/central venous line and multiple births (e.g., twins, triplets) will be excluded.</p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<p>\n Study staff will ask the infant caregivers for their informed written consent to conduct the screening procedures (i.e., measure the infant’s weight, review the mother’s and infant’s hospital records and determine inclusion and exclusion criteria). Some infants (30%) will be randomly selected to provide stool sample at enrollment, day 7, week 4 and month 6 of age. Mothers of these babies will also be asked for a stool sample collected within 48 hours of giving birth. Randomized infants will receive the study supplements daily for 28 days and followed up monthly until month 6.</p>\n<p>\n <strong>What are the benefits and risks of the study for those involved?</strong></p>\n<p>\n There is no direct benefit for taking part in the study, however, participants will receive examination and advice for treatment of illnesses. There is a small risk that the organisms in the probiotic could enter the blood stream and cause infection.</p>\n<p>\n <strong>How will the study benefit society?</strong></p>\n<p>\n The study results will help answer important research questions about probiotics in preterm and SGA babies under six months.</p>\n<p>\n <strong>When does the study start and finish?</strong></p>\n<p>\n Participant recruitment will begin after receipt of ethical and regulatory approvals and be completed within 28 months.</p>\n
      • short_titlePROPS Trial
      • protocol_noECCT/25/07/03
      • version_no1.4
      • date_of_protocol10-11-2025
      • study_drugLactobacillus rhamnosus GG DSM33156 and Bifidobacterium longum subsp. Infantis DSM33361
      • disease_conditionMalnutrition
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssingabo2008@gmail.com
      • applicant_covering_letter1
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      • applicant_investigators_cv1
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      • applicant_indemnity_cover1
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      • applicant_participating_countries(null)
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      • applicant_detailed_budget1
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantJoyce Akuka
      • declaration_date124-03-2026
      • declaration_principal_investigatorBenson Singa
      • declaration_date224-03-2026
      • placebo_presentYes
      • study_objectives<p>\n The overall objective of the trial is to assess the effect of probiotic supplementation on mortality, morbidity, and growth in preterm or term SGA infants in the first 6 months of life in South Asia and Sub-Saharan Africa.</p>\n<h2>\n Primary Objective</h2>\n<p>\n In preterm infants: to assess the effect of probiotic supplementation on all-cause mortality from enrolment to 6 months.</p>\n<p>\n In term SGA infants: to assess the effect of probiotic supplementation on ‘underweight-free survival’ at 6 months.</p>\n<h2>\n Secondary Objectives</h2>\n<p style=\"margin-left: 29.2pt;\">\n       i.      To assess the effect of probiotic supplementation on the following outcomes at hospital discharge, 1 month and 6 months of age:</p>\n<p style=\"margin-left: 32.05pt;\">\n a)    all-cause mortality (for the 6-month endpoint, this will be evaluated as a secondary outcome for term SGA infants, and as a primary outcome for preterm infants) and cause specific mortality due to necrotising enterocolitis, sepsis, severe diarrhoea</p>\n<p style=\"margin-left: 32.05pt;\">\n b)    episodes of necrotising enterocolitis, sepsis, severe diarrhoea</p>\n<p style=\"margin-left: 32.05pt;\">\n c)     episodes of pathogen specific sepsis (including <em>Streptococcus, Staphylococcus, Klebsiella, Escherichia coli, Acinetobacter spp) including their</em> serotypes and genotypic sequences</p>\n<p style=\"margin-left: 32.05pt;\">\n d)    episodes of hospitalisation</p>\n<p style=\"margin-left: 29.2pt;\">\n      ii.      To assess the effect of probiotic supplementation on the prevalence of wasting, underweight, and mean weight for age z score (WAZ) and weight for length (WLZ) scores at 6 months of age</p>\n<p style=\"margin-left: 29.2pt;\">\n     iii.      To assess the effect of probiotic supplementation on the abundance of <em>B. Infantis</em> and <em>L. rhamnosus </em>and other bacteria in infant faecal specimens at enrolment, 7 days, 28 days and 6 months of age; and in maternal faecal specimens at enrolment, including their serotypes and genotypic sequences.</p>\n<p style=\"margin-left: 29.2pt;\">\n     iv.      To assess the effect of probiotic supplementation on the primary outcome in the following subgroups:</p>\n<p style=\"margin-left: 32.05pt;\">\n a)    prematurity (<32weeks, 32-<37weeks)</p>\n<p style=\"margin-left: 32.05pt;\">\n b)    birth weight (< 1.5kg, 1.5 to < 2.5kg, 2.5+ kg)</p>\n<p style=\"margin-left: 32.05pt;\">\n c)     preterm and SGA status (preterm SGA, preterm AGA, term SGA) </p>\n<p style=\"margin-left: 32.05pt;\">\n d)    vaccination (fully, partially, not vaccinated) from enrolment to 6 months of age</p>\n<p style=\"margin-left: 32.05pt;\">\n e)    feeding type (exclusive, predominant, partial) at 1 month, 3 months, 6 months of age</p>\n<p style=\"margin-left: 32.05pt;\">\n f)      early initiation of enteral feeding (including mother’s milk, donor milk, infant formula) (within < 1hour, 2-< 24hour, 24+ hours after birth)</p>\n<p style=\"margin-left: 32.05pt;\">\n g)    micronutrient supplement intake (multiple micronutrients, iron, vitamin A, vitamin D, zinc) from enrolment to 6 months of age</p>\n<p style=\"margin-left: 32.05pt;\">\n h)    receipt of antibiotics from enrolment to 6 months of age</p>\n<h2>\n Safety Objectives</h2>\n<p>\n To assess the effect of probiotic supplementation on the following outcomes in both preterm and term SGA infants from enrolment to 6 months of age:</p>\n<p style=\"margin-left: 32.05pt;\">\n a)    episodes of serious adverse events (SAEs) (as defined in table 2 below)</p>\n<p style=\"margin-left: 32.05pt;\">\n b)    episodes of sepsis due to the probiotic strains <em>B. Infantis</em> or <em>L. rhamnosus GG</em></p>\n
      • principal_inclusion_criteria<p style=\"margin-left:36pt;\">\n i.         < 48 hours of age at the time of enrolment</p>\n<p style=\"margin-left:36pt;\">\n ii.         Preterm (AGA or SGA) or term SGA infants</p>\n<p style=\"margin-left:36pt;\">\n iii.         Likely to be in the study area for the next 6 months</p>\n
      • principal_exclusion_criteria<p style=\"margin-left:36pt;\">\n        i.         < 28-week gestation</p>\n<p style=\"margin-left:36pt;\">\n      ii.         Not taking enteral feeds (e.g., due to a major congenital abnormality, mechanically ventilated, post-surgery or too unwell to be fed)</p>\n<p style=\"margin-left:36pt;\">\n     iii.         Confirmed sepsis at the time of enrolment</p>\n<p style=\"margin-left:36pt;\">\n     iv.         Indwelling central lines (including umbilical catheter/central venous line) (infants with peripheral intravenous lines will not be excluded)</p>\n<p style=\"margin-left:35.7pt;\">\n      v.         Multiple births (e.g., twins, triplets)</p>\n
      • primary_end_points<div class=\"page\" title=\"Page 8\">\n <div class=\"layoutArea\">\n <div class=\"column\">\n <p>\n <span style=\"font-size: 6.000000pt; font-family: \'DejaVuSans\'\"> </span></p>\n </div>\n </div>\n</div>\n<p new=\"\" style=\"margin-right: 0cm; margin-left: 36pt; font-size: 12pt; font-family: \" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Arial, sans-serif;\"><span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span>i.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">         </span></span><span style=\"font-size: 11pt; font-family: Arial, sans-serif;\">All-cause mortality<o:p></o:p></span></p>\n<p new=\"\" style=\"margin-right: 0cm; margin-left: 36pt; font-size: 12pt; font-family: \" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Arial, sans-serif;\"><span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span>ii.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">         </span></span><span style=\"font-size: 11pt; font-family: Arial, sans-serif;\">Underweight free survival<o:p></o:p></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span class=\"selected\"><span style=\"font-size: 12pt; font-family: Calibri, sans-serif;\">The study site has adequate physical infrastructure, including dedicated and secure spaces for IMP storage, biological sample processing, data management (secure data room with lockable cabinets), and clinical procedures (newborn unit and designated clinical room with emergency cart). The study site is supported by a dedicated, team covering all essential activities, including screening, enrolment, IMP management and delivery, outcome assessment, laboratory procedures, data management, and regulatory oversight. All staff will receive thorough training on the protocol, SOPs, ICH-GCP, and trial-specific requirements. </span></span></p>\n<p new=\"\" style=\"margin: 0cm 0cm 6pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n Key personnel and their roles include:<o:p></o:p></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 10pt; font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span>Investigators: Medical doctors with extensive clinical research experience, providing medical oversight, study design expertise, and patient management.<o:p></o:p></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 10pt; font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">   </span></span>Trial Manager (BSc, MPH): Oversees overall operational management, ensuring protocol adherence, timelines, and resource allocation.<o:p></o:p></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 10pt; font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span>Study Coordinator (BSc): Manages day-to-day activities, including recruitment, scheduling, data collection, and communication.<o:p></o:p></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 10pt; font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span>Pharmacist: Licensed professional responsible for IMP management.<o:p></o:p></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 10pt; font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span>Regulatory Manager (BSc): Ensures compliance with national and international regulatory guidelines and ethical standards.<o:p></o:p></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 10pt; font-family: Symbol;\">·<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-size-adjust: none; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-variant-emoji: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span>Lab Manager (BSc, MPH): Oversees all laboratory procedures, ensuring sample integrity and quality control.</p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-family: Calibri, sans-serif; font-size: 12pt;\">. Data Manager (BSc): Designs, implements, and maintains the study's data management system, ensuring data quality and security.</span></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span class=\"selected\"><span style=\"font-size: 12pt; font-family: Calibri, sans-serif;\">Should a medical emergency arise, immediate care will be provided by the site principal investigator or a designated medically competent individual. During regular clinical procedures, immediate basic life support measures will be implemented. For emergencies outside trial working hours, participants will contact the study team who will arrange for care. Clinical procedures are conducted in a designated, well-equipped clinical room, which includes an emergency cart.</span></span></p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n  </p>\n<p new=\"\" style=\"margin: 0cm 0cm 0cm 36pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-family: Calibri, sans-serif;\">The study team has a strong track record in clinical research and understanding of local community dynamics. The site is equipped with essential and calibrated instruments, including weighing scales, refrigerators, and automated temperature dataloggers.</span></p>\n
      • other_details_explanation<p>\n Kenya faces a high burden of preterm and small for gestational age (SGA) births, leading to significant infant morbidity and mortality.</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 Not applicable</p>\n
      • estimated_duration28 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_statesFive (5)
      • number_of_sitesFour (4)
      • multi_country_listBangladesh, Pakistan, Kenya, Ethiopia and Nigeria
      • data_monitoring_committeeYes
      • total_enrolment_per_siteAs enrollment is competitive, there isn\'t a fixed number for each site. However, to ensure equitable distribution and successful recruitment, we anticipate a minimum of approximately 600 participants per site and a maximum of around 800 participants per site, depending on the competitive recruitment outcomes.
      • total_participants_worldwide14000 (9500 preterm < 37 weeks and 4500 term SGA)
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyNewborns
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBenson
      • investigator1_middle_name
      • investigator1_family_nameSinga
      • investigator1_qualificationMBChB
      • investigator1_professional_address54840-00200
      • investigator1_telephone0725234844
      • investigator1_emailsingabo2008@gmail.com
      • organisations_transferred_Yes
      • number_participants2900 (2000 preterm < 37 weeks and 900 term SGA)
      • notification<p>\n Thank you for your valuable time and attention to this application.</p>\n
      • approval_date14-04-2026
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-03-2026
      • is_child0
      • unsubmitted1
      • initial_date_submitted15-10-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewed and 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)
      • modified2026-04-14 21:50:55
      • created2025-07-02 16:45:24
      • total_sites1
      • ecitizen_invoice379754
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1316
        • application_id1566
        • given_nameJoyce
        • middle_name
        • family_nameAkuka
        • qualificationMBChB
        • professional_address202-40400
        • telephone0710933251
        • emailjoyceakuka@gmail.com
        • investigator_roleprincipal
        • created2025-07-02 16:57:41
        • modified2026-03-25 11:02:01
    • SiteDetail(array)
      • 0(array)
        • id1952
        • application_id1566
        • county_id44
        • site_nameMigori County Referral Hospital
        • physical_addressMigori town
        • contact_detailsP.O. Box 202-40400 Suna-Migori
        • contact_personJoyce Akuka
        • site_capacity(null)
        • misc(null)
        • created2025-07-02 16:57:41
        • modified2026-03-25 11:02:01
        • County(array)
          • id44
          • county_nameMigori
          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
      • 1(array)
        • id1953
        • application_id1566
        • county_id43
        • site_nameHomabay County Referral Hospital
        • physical_addressHoma Bay school road, off salama road
        • contact_detailsP.O. Box 52-40300 Homa Bay, Kenya
        • contact_personMeshack Liru
        • site_capacity(null)
        • misc(null)
        • created2025-07-02 17:24:38
        • modified2026-03-25 11:02:01
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 2(array)
        • id1954
        • application_id1566
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressAlong Kisumu – Kakamega Road
        • contact_detailsP.O. Box 849-40100 Kisumu
        • contact_personMaureen Muchela
        • site_capacity(null)
        • misc(null)
        • created2025-07-02 17:24:38
        • modified2026-03-25 11:02:01
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 3(array)
        • id1955
        • application_id1566
        • county_id45
        • site_nameKisii Teaching and Referral Hospital
        • physical_addressAlong Hispital Road, Kisii Town
        • contact_detailsP.O. Box 92-40200 Kisii
        • contact_personMourine Ikol
        • site_capacity(null)
        • misc(null)
        • created2025-07-02 17:24:38
        • modified2026-03-25 11:02:01
        • County(array)
          • id45
          • county_nameKisii
          • created2012-06-15 10:27:25
          • modified2012-06-15 10:27:25
    • Sponsor(array)
      • 0(array)
        • id851
        • application_id1566
        • sponsorWorld Health Organization
        • sponsor_typeOthers
        • contact_personKaren Edmond
        • address20, AVENUE APPIA, 1211 GENEVA 27, SWITZERLAND
        • telephone_number+41 22 791 2111
        • fax_number
        • cell_number+ 41 795 839 349
        • email_addressedmondk@who.int
        • created2025-07-02 16:57:41
        • modified2026-03-25 11:02:01
  • 2(array)
    • Application(array)
      • id1562
      • user_id294
      • trial_status_id2
      • abstract_of_study<p>\n Preterm and small for gestational age (SGA) infants have a 2- to 10-fold higher risk of mortality than infants born at term and with normal birth weight, and are particularly vulnerable to infection, malabsorption, necrotizing enterocolitis, difficulty feeding, and growth failure. Numerous trials conducted in the last ten years have reported that probiotics can improve short- and long-term mortality, necrotizing enterocolitis and sepsis rates, and growth and neurodevelopment in preterm and low birth weight infants. However, most trials have been small and with high to moderate risk of bias. There have been no trials in SGA infants. The World Health Organization (WHO) guideline development group (GDG) and other organizations have recommended that further large high-quality trials are implemented to provide evidence of sufficient quality and applicability to inform policy and practice. The overall aim of this trial is to assess the effect of probiotic supplementation on mortality, morbidity, and growth in preterm or term SGA infants in the first 6 months of life in South Asia and Sub-Saharan Africa. The trial is a multi-country multi-centre individually-randomised double-blind parallel-group placebo-controlled superiority trial implemented in five countries: two in Asia (Bangladesh, Pakistan) and three in Africa (Ethiopia, Nigeria, Kenya). A total of 14,000 (2900 in Kenya) eligible infants will be enrolled across the 5 participating countries and randomly assigned to either the intervention or control group separately for the preterm and term SGA infants. Each randomized infant will receive the study supplements (probiotics or placebo) daily for 28 days and followed up monthly for primary and secondary outcome endpoint assessment by an independent outcome assessment team until the infant reaches 6 months of age. Endpoint data will also be collected on all infants admitted to study hospitals. Results from this trial will help inform policy and practice for probiotic supplementation in preterm and SGA infants, improve the certainty of evidence on critical outcomes and strengthen the understanding of optimal strains, dosing and duration of probiotic supplementation and related impact in high burden LMICs.</p>\n
      • study_title<p align=\"center\">\n <strong>Efficacy of probiotic supplementation in preterm and small for gestational age infants. A multi-centre, placebo-controlled, individually-randomised trial</strong></p>\n<p>\n <strong>(Probiotics in preterm and small for gestational age infants, PROPS trial)</strong></p>\n
      • laymans_summary<p>\n <strong>What is the problem?</strong></p>\n<p>\n Babies born before their due date for delivery(preterm) and babies born small for gestational age (SGA) infants have 2-10 times higher risk of death than infants born at term and with normal birth weight, and are particularly vulnerable to infection, malabsorption, severe bowel infection, difficulty feeding, and growth failure. Improvements in outcomes in preterm and SGA infants have been slow in all countries, especially low- and middle- income countries (LMICs), due to the complexities of preventing complications and providing medical care for small and vulnerable infants.</p>\n<p>\n <strong>What question are we trying to answer?</strong></p>\n<p>\n We aim to test the effect of probiotic supplementation on death, diseases, and growth in preterm or term SGA infants in the first 6 months of life in South Asia and Sub-Saharan Africa.</p>\n<p>\n <strong>Where is the study taking place? </strong></p>\n<p>\n The study will be conducted in five hospitals in Kenya namely; Migori County Referral Hospital, Homabay County Referral Hospital, Kisii Teaching and Referral Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital. Recruitment may also take place at St. Joseph’s Mission Hospital and Kendu Bay Mission Hospital. Other participating countries include Bangladesh, Pakistan, Ethiopia and Nigeria.</p>\n<p>\n <strong>How many people does it involve and how are they selected?</strong></p>\n<p>\n The study will enroll 2,900 eligible infants in Kenya (14,000 across the 5 participating countries). Eligible infants include preterm (AGA or SGA) or term SGA infants, aged less than 48 hours at the time of enrollment and likely to be in the study area for the next 6 months. Infants who are less than 28 weeks gestation, not able to take orall feeds, confirmed blood stream infection at the time of enrolment, indwelling umbilical catheter/central venous line and multiple births (e.g., twins, triplets) will be excluded.</p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<p>\n Study staff will ask the infant caregivers for their informed written consent to conduct the screening procedures (i.e., measure the infant’s weight, review the mother’s and infant’s hospital records and determine inclusion and exclusion criteria). Some infants (30%) will be randomly selected to provide stool sample at enrollment, day 7, week 4 and month 6 of age. Mothers of these babies will also be asked for a stool sample collected within 48 hours of giving birth. Randomized infants will receive the study supplements daily for 28 days and followed up monthly until month 6.</p>\n<p>\n <strong>What are the benefits and risks of the study for those involved?</strong></p>\n<p>\n There is no direct benefit for taking part in the study, however, participants will receive examination and advice for treatment of illnesses. There is a small risk that the organisms in the probiotic could enter the blood stream and cause infection.</p>\n<p>\n <strong>How will the study benefit society?</strong></p>\n<p>\n The study results will help answer important research questions about probiotics in preterm and SGA babies under six months.</p>\n<p>\n <strong>When does the study start and finish?</strong></p>\n<p>\n Participant recruitment will begin after receipt of ethical and regulatory approvals and be completed within 28 months.</p>\n
      • short_titlePROPS Trial
      • protocol_noECCT/25/07/02
      • version_no1.4
      • date_of_protocol10-11-2025
      • study_drugLactobacillus rhamnosus GG DSM33156 and Bifidobacterium longum subsp. Infantis DSM33361
      • disease_conditionMalnutrition
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssingabo2008@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_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_applicantMeshack Liru
      • declaration_date124-03-2026
      • declaration_principal_investigatorBenson Singa
      • declaration_date224-03-2026
      • placebo_presentYes
      • study_objectives<p>\n <strong>Overall objective</strong></p>\n<p>\n To assess the effect of probiotic supplementation on mortality, morbidity, and growth in preterm or term SGA infants in the first 6 months of life in South Asia and Sub-Saharan Africa.</p>\n<p>\n <strong>Primary Objective</strong></p>\n<p>\n In preterm infants: to assess the effect of probiotic supplementation on all-cause mortality from enrolment to 6 months.</p>\n<p>\n In term SGA infants: to assess the effect of probiotic supplementation on ‘underweight-free survival’ at 6 months.</p>\n<p>\n <strong>Secondary Objectives</strong></p>\n<p style=\"margin-left:26.35pt;\">\n  i.         To assess the effect of probiotic supplementation on the following outcomes at hospital discharge, 1 month and 6 months of age:</p>\n<p style=\"margin-left:46.2pt;\">\n a.     all-cause mortality (for the 6-month endpoint, this will be evaluated as a secondary outcome for term SGA infants, and as a primary outcome for preterm infants) and cause specific mortality due to necrotising enterocolitis, sepsis, severe diarrhoea</p>\n<p style=\"margin-left:46.2pt;\">\n b.     episodes of necrotising enterocolitis, sepsis, severe diarrhoea</p>\n<p style=\"margin-left:46.2pt;\">\n c.     episodes of pathogen specific sepsis (including <em>Streptococcus, Staphylococcus, Klebsiella, Escherichia coli, Acinetobacter spp) including their</em> serotypes and genotypic sequences</p>\n<p style=\"margin-left:46.2pt;\">\n d.     episodes of hospitalisation</p>\n<p style=\"margin-left:26.35pt;\">\n ii.         To assess the effect of probiotic supplementation on the prevalence of wasting, underweight, and mean weight for age z score (WAZ) and weight for length (WLZ) scores at 6 months of age</p>\n<p style=\"margin-left:26.35pt;\">\n iii.         To assess the effect of probiotic supplementation on the abundance of <em>B. Infantis</em> and <em>L. rhamnosus </em>and other bacteria in infant faecal specimens at enrolment, 7 days, 28 days and 6 months of age; and in maternal faecal specimens at enrolment, including their serotypes and genotypic sequences.</p>\n<p style=\"margin-left:26.35pt;\">\n iv.         To assess the effect of probiotic supplementation on the primary outcome in the following subgroups:</p>\n<p style=\"margin-left:46.2pt;\">\n a.     prematurity (<32weeks, 32-<37weeks)</p>\n<p style=\"margin-left:46.2pt;\">\n b.     birth weight (< 1.5kg, 1.5 to < 2.5kg, 2.5+ kg)</p>\n<p style=\"margin-left:46.2pt;\">\n c.     preterm and SGA status (preterm SGA, preterm AGA, term SGA) </p>\n<p style=\"margin-left:46.2pt;\">\n d.     vaccination (fully, partially, not vaccinated) from enrolment to 6 months of age</p>\n<p style=\"margin-left:46.2pt;\">\n e.     feeding type (exclusive, predominant, partial) at 1 month, 3 months, 6 months of age</p>\n<p style=\"margin-left:46.2pt;\">\n f.      early initiation of enteral feeding (including mother’s milk, donor milk, infant formula) (within < 1hour, 2-< 24hour, 24+ hours after birth)</p>\n<p style=\"margin-left:46.2pt;\">\n g.     micronutrient supplement intake (multiple micronutrients, iron, vitamin A, vitamin D, zinc) from enrolment to 6 months of age</p>\n<p style=\"margin-left:46.2pt;\">\n h.     receipt of antibiotics (by AWaRe classification [Access, Watch, Reserve]) from enrolment to 6 months of age</p>\n<p>\n <strong>Safety Objectives</strong></p>\n<p>\n To assess the effect of probiotic supplementation on the following outcomes in both preterm and term SGA infants from enrolment to 6 months of age:</p>\n<p style=\"margin-left:46.2pt;\">\n a.     episodes of serious adverse events (SAEs)</p>\n<p style=\"margin-left:46.2pt;\">\n b.     episodes of sepsis due to the probiotic strains <em>B. Infantis</em> or <em>L. rhamnosus GG</em></p>\n
      • principal_inclusion_criteria<p style=\"margin-left:36pt;\">\n        i.         < 48 hours of age at the time of enrolment</p>\n<p style=\"margin-left:36pt;\">\n      ii.         Preterm (AGA or SGA) or term SGA infants</p>\n<p style=\"margin-left:36pt;\">\n     iii.         Likely to be in the study area for the next 6 months</p>\n
      • principal_exclusion_criteria<p style=\"margin-left:36pt;\">\n        i.         < 28-week gestation</p>\n<p style=\"margin-left:36pt;\">\n      ii.         Not taking enteral feeds (e.g., due to a major congenital abnormality, mechanically ventilated, post-surgery or too unwell to be fed)</p>\n<p style=\"margin-left:36pt;\">\n     iii.         Confirmed sepsis at the time of enrolment</p>\n<p style=\"margin-left:36pt;\">\n     iv.         Indwelling central lines (including umbilical catheter/central venous line) (infants with peripheral intravenous lines will not be excluded)</p>\n<p style=\"margin-left:35.7pt;\">\n      v.         Multiple births (e.g., twins, triplets)</p>\n
      • primary_end_points<p>\n All-cause mortality</p>\n<p>\n Underweight free survival</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:35.7pt;\">\n <strong>      i.         </strong><strong>Staffing and responsibilities:</strong></p>\n<p>\n The trial will be supported by a dedicated team covering all essential activities, including screening, enrolment, Investigational Medicinal Product (IMP) management and delivery, outcome assessment, laboratory procedures, data management, and regulatory oversight and compliance. The entire study team is dedicated to this clinical trial, ensuring no conflicts of interest. Before the study begins, all staff will receive thorough training on the protocol, relevant SOPs, ICH-GCP guidelines, and trial-specific requirements.</p>\n<p>\n Coordinating Principal Investigator (PI) - Responsible for the overall scientific and administrative oversight of the entire multi-site study. This includes developing the unified research protocol, ensuring consistency across all participating sites, managing central data analysis, and serving as the primary liaison with regulatory bodies and funding agencies for the overarching study.</p>\n<p>\n Site Principal Investigator<strong> - </strong>Responsible for the day-to-day scientific and operational conduct of the study specifically at the study site. This encompasses ensuring adherence to the study protocol locally, managing the site's research team, overseeing participant recruitment and data collection at the site level, and ensuring compliance with all local ethical and regulatory requirements.</p>\n<p>\n Trial Manager - Oversees the day-to-day operational aspects of the study, ensuring adherence to timelines, budgets, and standard operating procedures (SOPs).</p>\n<p>\n Study Coordinator - Manages participant recruitment, scheduling, data collection, and assists the Site PI with various study-related tasks.</p>\n<p>\n Screening Team - Identifies, consents, and screens participants.</p>\n<p>\n Enrolment Team - Obtains main trial consent and collects baseline data.</p>\n<p>\n IMP Management Team - Manages all aspects of the IMP, including ordering, receipt, storage, dispensing, and accountability.</p>\n<p>\n IMP Delivery Team - Delivers IMP daily to participants at the hospital, home, or a convenient caregiver-chosen location.</p>\n<p>\n Outcome Assessment Team - Collects data on vital status, illnesses, healthcare use, feeding practices, anthropometry, and specimens.</p>\n<p>\n Laboratory Team - Handles sample processing and shipment to the central laboratory.</p>\n<p>\n Data Management Team - Implements clinical data management plans, develops data entry guidelines, and oversees data quality control.</p>\n<p>\n Regulatory Compliance Team - Ensures adherence to ethical and legal standards, and manages all ethics and regulatory documentation.</p>\n<p>\n  </p>\n<p style=\"margin-left:35.7pt;\">\n <strong>    ii.         </strong><strong>Emergency Procedures:</strong></p>\n<p>\n Should a medical emergency arise in the presence of the study physician or another medically competent individual, immediate care must be provided to the participant. If such an emergency occurs during regular clinical procedures, immediate basic life support measures will be implemented. If a medical emergency occurs out of trial working hours, the participant will contact the study team who will make arrangement for the participant to receive care. Medical emergencies will be documented as either AE, AESIs or SAE, according to the safety management plan.</p>\n<p>\n  </p>\n<p style=\"margin-left:35.7pt;\">\n <strong>   iii.         </strong> <strong>Equipment</strong><strong>:</strong></p>\n<p>\n The study site has all essential instruments for the clinical trial, including calibrated we</p>\n
      • other_details_explanation<p>\n Not applicable</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 Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration28 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_statesFive (5)
      • number_of_sitesFour (4)
      • multi_country_listBangladesh, Pakistan, Kenya, Ethiopia and Nigeria
      • data_monitoring_committeeYes
      • total_enrolment_per_siteAs enrollment is competitive, there isn\'t a fixed number for each site. However, to ensure equitable distribution and successful recruitment, we anticipate a minimum of approximately 600 participants per site and a maximum of around 800 participants per site, depending on the competitive recruitment outcomes.
      • total_participants_worldwide14000 (9500 preterm < 37 weeks and 4500 term SGA)
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyNeonates
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBenson
      • investigator1_middle_name
      • investigator1_family_nameSinga
      • investigator1_qualificationMBChB
      • investigator1_professional_addressKenya Medical Research Institute P.O. Box 54840-00200 Nairobi
      • investigator1_telephone0725234844
      • investigator1_emailsingabo2008@gmail.com
      • organisations_transferred_Yes
      • number_participants2900 (2000 preterm < 37 weeks and 900 term SGA)
      • notification<p>\n Thank you for your valuable time and attention to this application.</p>\n
      • approval_date14-04-2026
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-03-2026
      • is_child0
      • unsubmitted1
      • initial_date_submitted15-10-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewed and 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)
      • modified2026-04-14 21:43:31
      • created2025-06-19 16:49:55
      • total_sites4
      • ecitizen_invoice378715
      • ai_content(null)
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      • 0(array)
        • id1309
        • application_id1562
        • given_nameMeshack
        • middle_name
        • family_nameLiru
        • qualificationMBChB
        • professional_addressHomabay County Referral Hospital P.O. Box 52-40300 Homabay
        • telephone0721863286
        • emaillirumeshack@gmail.com
        • investigator_roleprincipal
        • created2025-06-19 17:58:20
        • modified2026-03-25 10:48:42
    • SiteDetail(array)
      • 0(array)
        • id1943
        • application_id1562
        • county_id43
        • site_nameHomabay County Referral Hospital
        • physical_addressHoma Bay school road, off salama road
        • contact_detailsP.O. Box 52-40300 Homa Bay, Kenya
        • contact_personDr. Meshack Liru
        • site_capacity(null)
        • misc(null)
        • created2025-06-19 17:58:20
        • modified2026-03-25 10:48:42
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          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 1(array)
        • id1944
        • application_id1562
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressAlong Kisumu – Kakamega Road
        • contact_detailsP.O. Box 849-40100 Kisumu
        • contact_personDr. Maureen Muchela
        • site_capacity(null)
        • misc(null)
        • created2025-06-20 11:36:50
        • modified2026-03-25 10:48:42
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          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1945
        • application_id1562
        • county_id45
        • site_nameKisii Teaching and Referral Hospital
        • physical_addressAlong Hispital Road, Kisii Town
        • contact_detailsP.O. Box 92-40200 Kisii
        • contact_personDr. Mourine Ikol
        • site_capacity(null)
        • misc(null)
        • created2025-06-20 11:56:30
        • modified2026-03-25 10:48:42
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          • id45
          • county_nameKisii
          • created2012-06-15 10:27:25
          • modified2012-06-15 10:27:25
      • 3(array)
        • id1946
        • application_id1562
        • county_id44
        • site_nameMigori County Referral Hospital
        • physical_addressMigori town
        • contact_detailsP.O. Box 202-40400 Suna-Migori
        • contact_personDr. Joyce Akuka
        • site_capacity(null)
        • misc(null)
        • created2025-06-20 11:56:30
        • modified2026-03-25 10:48:42
        • County(array)
          • id44
          • county_nameMigori
          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
    • Sponsor(array)
      • 0(array)
        • id848
        • application_id1562
        • sponsorWorld Health Organization
        • sponsor_typeOthers
        • contact_personDr Karen Edmond
        • address20, AVENUE APPIA, 1211 GENEVA 27, SWITZERLAND
        • telephone_number+41 22 791 2111
        • fax_number
        • cell_number+ 41 795 839 349
        • email_addressedmondk@who.int
        • created2025-06-19 17:58:20
        • modified2026-03-25 10:48:42
  • 3(array)
    • Application(array)
      • id1173
      • user_id667
      • trial_status_id6
      • abstract_of_study<h1>\n ABSTRACT </h1>\n<p>\n HIV incidence rates remain unacceptably high for adolescent girls and young women (AGYW). Pre-exposure prophylaxis (PrEP) HIV prevention tools are promising with tenofovir (TFV)-based daily oral PrEP and the dapivirine vaginal ring (DPV-VR) recommended by WHO for cisgender women at-risk for HIV. Kenya is a leader for PrEP delivery in Africa and efforts are ongoing to increase PrEP access with AGYW as a priority group. Our team pioneered integrated PrEP delivery in family planning (FP) clinics in Kenya; yet 40% of Kenyan women access contraception without interfacing with facilities, including at retail pharmacies, and would be missed by facility-based PrEP platforms. Retail pharmacies can increase options for reaching at-risk individuals with PrEP and efforts are underway to define pathways for pharmacy-delivered PrEP in Kenya. We adapted our FP clinic-based PrEP model and piloted PrEP delivery facilitated by nurse-navigators for AGYW seeking contraception at pharmacies. AGYW offered daily oral PrEP frequently initiated, planned to continue use, and were willing to pay for PrEP at pharmacies. Pill burden was a common reason for declining oral PrEP and could be addressed by offering DPV-VR. Through close collaboration with the Kenya Ministry of Health both, national- and county-level, we propose a Cluster Random Controlled Trial( cRCT() at 20 pharmacies in Kisumu, Kenya-a region with an HIV prevalence of up to 28% among women -to test the effectiveness of utilizing nurse-navigators at retail pharmacies to enhance AGYW PrEP use. We will expand on our successful pilot to offer both daily oral PrEP and the DPV-VR and prospectively ascertain PrEP outcomes (initiation, persistence, adherence) among AGYW. This effectiveness-implementation hybrid RCT is designed to expedite translation into practice by evaluating clinical effectiveness alongside implementation and cost outcomes. We hypothesize that combining nurse-navigators with pharmacy-based PrEP will provide a cost-effective strategy for delivering novel HIV prevention tools to AGYW in HIV high-burden settings. Aim 1 will determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model through a 2-arm cluster RCT among HIV-negative AGYW at 20 retail pharmacies in Kisumu, Kenya. AGYW seeking contraception will be offered PrEP and self-select daily oral PrEP or the DPV-VR. Primary outcomes will be proportion of AGYW accessing contraception that initiate PrEP, persist with use at 6 months, and adhere (quantified by TFV or DPV hair levels). Secondary outcomes will include PrEP selection (PrEP pills vs. DPV-VR), STI incidence, and adherence cofactors. Aim 2 will identify potential barriers and facilitators to acceptability, feasibility, and sustainability of nurse-navigators and DPV-VR delivery for AGYW accessing PrEP at retail pharmacies through a qualitative evaluation guided by Proctor et al. Aim 3 will estimate the cost-effectiveness of implementing pharmacy-based PrEP delivery with nurse-navigators. This will be the first study aiming to improve PrEP access for AGYW using a pharmacy-based model and will prime pharmacies to deliver novel PrEP agents in the pipeline.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Enhancing PrEP outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform</strong></p>\n<p>\n  </p>\n
      • laymans_summary<div>\n <p>\n <strong>LAY SUMMARY</strong></p>\n <p>\n Pre- exposure prophylaxis (PrEP) is a HIV prevention method available in both a daily oral form (tenofovir) or a monthly vaginal ring (dapivirine), PrEP works when used as recommended. Increasing locations where PrEP is dispensed may make it easier for adolescent girls and young women (AGYW) to access PrEP. To date, PrEP is available at public health clinics, yet there are major barriers to accessing PrEP at clinics which includes stigma, long waiting times, staffing costs, and healthcare providers’ unfamiliarity with PrEP. In Kenya, people often go to retail pharmacies first access to treatment of urgent and prolonged conditions. AGYW frequently obtain contraception at pharmacies without attending a health facility. Potential PrEP users may prefer pharmacy-delivered PrEP due to convenience and privacy. Additionally, the presence of nurses to provide tailored counselling on PrEP use and related topics in pharmacies can facilitate PrEP use. We will offer PrEP to AGYW  at pharmacies with and without nurses to assess if nurse-navigators effect PrEP use and determine the costs of PrEP delivery in pharmacies.</p>\n</div>\n<p>\n  </p>\n
      • short_titleAGYW Pharmacy PrEP Delivery
      • protocol_noECCT/22/10/01
      • version_no1.0
      • date_of_protocol21-03-2021
      • study_drugDapivirine
      • disease_conditionHuman Immunodeficiency Virus (HIV)
      • 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_nameDapivirine
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameTenofovir Emtricitabine
      • comparator_registeredyes
      • comparator_countriesKenya, Zambia, Botswana, Zimbabwe
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGreshon Rota
      • declaration_date104-10-2022
      • declaration_principal_investigatorElizabeth Bukusi
      • declaration_date204-10-2022
      • placebo_presentNo
      • study_objectives<p>\n Our overarching aim is to determine the effectiveness of utilizing nurse navigators at retail pharmacies to enhance the use of pre-exposure prophylaxis (PrEP) use for HIV prevention among adolescent girls and young women. We propose to determine the effect of nurse navigators vs. standard of care (i.e., pharmacy provider-delivered PrEP), in a 2-armed cluster randomized controlled trial (RCT). </p>\n<p>\n  </p>\n<p>\n <u>The primary objectives of this evaluation are to:</u></p>\n<p>\n  </p>\n<ol>\n <li>\n To determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among HIV-negative AGYW (age 14-24 years) seeking contraception by comparing pharmacy-based PrEP delivery models with and without nurse-navigators at 20 retail pharmacies in Kisumu, Kenya.\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <u>Secondary objectives:</u>\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n To compare PrEP selection (pills vs. DPV-VR), STI incidence and adherence cofactors (e.g. depression, relationship climate) by randomization arm.</li>\n <li>\n To describe HIV incidence, quality of care measures and long-acting reversible contraceptive use.</li>\n </ol>\n </li>\n </ol>\n </li>\n <li>\n To evaluate implementation outcomes (acceptability, feasibility, and client satisfaction) of incorporating nurse-navigators and DPV-VR into pharmacy-based PrEP delivery for AGYW by conducting a qualitative evaluation at the individual, provider, and system-level to inform scale up guided by the Proctor model.¹</li>\n <li>\n To estimate the costs and cost-effectiveness of implementing pharmacy-based PrEP delivery with nurse-navigators compared to standard pharmacy-based PrEP by conducting micro-costing and time-and-motion observation to estimate costs.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<h3>\n 5.3 Eligibility Criteria </h3>\n<p>\n  </p>\n<ol>\n <li>\n <strong>AGYW (PrEP screening) </strong></li>\n</ol>\n<ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n</ol>\n<ul>\n <li>\n Female gender </li>\n <li>\n Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between ≥14 and <25 years old </li>\n <li>\n Willingness to receive PrEP screening per national guidelines including HIV testing </li>\n <li>\n Not currently taking PrEP </li>\n <li>\n Able and willing to provide informed consent for participation </li>\n</ul>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n <strong>AGYW (PrEP offer per NASCOP guidelines) </strong></li>\n</ol>\n<ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n</ol>\n<ul>\n <li>\n Meets NASCOP PrEP eligibility criteria. PrEP is offered to sexually active HIV-negative individuals who are at significant risk of acquiring HIV infection. Clients must meet ALL of the following criteria before initiating PrEP: </li>\n</ul>\n<ol>\n <li>\n At high risk for acquiring HIV, by meeting ANY of the following indications </li>\n</ol>\n<ul>\n <li>\n Sexual partner is known HIV positive and: not on ART, or on ART < 6 months, or suspected poor adherence to ART, or most recent viral load is detectable </li>\n <li>\n Sexual partner/s are of unknown HIV status and are at high-risk for HIV infection (has multiple sexual partners, has had STIs, engages in transactional sex, injects drugs, from high HIV burden settings) </li>\n <li>\n Engaging in transactional sex </li>\n <li>\n History of recent sexually transmitted infection </li>\n</ul>\n<ul>\n <li>\n Recurrent use of post-exposure prophylaxis </li>\n <li>\n History of sex whilst under the influence of alcohol or drugs  </li>\n <li>\n Inconsistent or no condom use or unable to negotiate condom use during intercourse with persons of unknown HIV status </li>\n <li>\n Injection drug use where needles and syringes are shared </li>\n <li>\n Sero-discordant couples trying to conceive </li>\n</ul>\n<ol>\n <li value=\"2\">\n Additionally, the following criteria must almost be met for PrEP initiation: </li>\n</ol>\n<ul>\n <li>\n Confirmed HIV negative (rapid antibody testing following the HTS algorithm on the day of PrEP initiation is adequate confirmation of HIV-negative status) </li>\n <li>\n Does not have a current or recent (within past one month) illness consistent with acute HIV infection (fever, sore throat, muscle or joint pains, swollen glands, diarrhoea or headache) in combination with a preceding high-risk exposure for HIV </li>\n <li>\n Assessed as ready to adhere to PrEP and willing to attend follow-up evaluations including repeat HIV testing and monitoring for side effects </li>\n <li>\n No contraindication to use of TDF +/- FTC/3TC </li>\n</ul>\n<p>\n  </p>\n<ol>\n <li value=\"3\">\n <strong>AGYW (FGDs) </strong>\n <ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n </ol>\n </li>\n</ol>\n<ul>\n <li>\n Female gender </li>\n <li>\n Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between ≥14 and <25 years old </li>\n <li>\n Willingness to receive PrEP screening per national guidelines including HIV testing </li>\n <li>\n Not currently taking PrEP </li>\n <li>\n Able and willing to provide informed consent for participation </li>\n <li>\n Randomized to the nurse-navigator arm</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li>\n <strong>AGYW (PrEP screening) </strong></li>\n <br />\n <li value=\"2\">\n <strong><em>Exclusion criteria</em></strong></li>\n</ol>\n<ul>\n <li>\n Male gender </li>\n <li>\n Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between <14 or >24 years old  </li>\n <li>\n Not willing to receive PrEP screening per national guidelines or not willing  to receive HIV testing </li>\n <li>\n Currently taking PrEP </li>\n <li>\n Not able or willing to provide informed consent for participation </li>\n</ul>\n<ol>\n <li value=\"2\">\n <strong>AGYW (Focused Group Discussions (FDGs)) </strong></li>\n</ol>\n<ol>\n <li value=\"2\">\n <strong><em>Exclusion criteria</em></strong></li>\n</ol>\n<ul>\n <li>\n Male gender </li>\n <li>\n Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between <14 or >24 years old  </li>\n <li>\n Not willing to receive PrEP screening per national guidelines or not willing  to receive HIV testing </li>\n <li>\n Currently taking PrEP </li>\n <li>\n Not able or willing to provide informed consent for participation </li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n Testing HIV Positive</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_others1
      • scope_others_specifyImplementation Science
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>FACILITY</u></strong></p>\n<p>\n  </p>\n<ol>\n <li>\n <strong>The main study site is:</strong></li>\n</ol>\n<p>\n KEMRI-RCTP</p>\n<p>\n KEMRI CIS Building</p>\n<p>\n Lumumba Sub-County Hospital</p>\n<p>\n Along Ondiek Highway</p>\n<p>\n P.O Box 614-40100</p>\n<p>\n Kisumu</p>\n<p>\n  </p>\n<p>\n The facility has</p>\n<ol>\n <li>\n Reception and waiting bay</li>\n <li>\n Six Clinic rooms</li>\n <li>\n Pharmacy</li>\n <li>\n Laboratory</li>\n <li>\n Data room</li>\n <li>\n Administration office</li>\n <li>\n Open Office</li>\n <li>\n Washrooms</li>\n</ol>\n<p>\n  </p>\n<p>\n All rooms are equipped with relevant furniture, equipment, and materials to facilitate the activities conducted in the rooms.</p>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n There will be <strong>20 retail pharmacies</strong> across Kisumu County based on whether they are willing to provide PrEP per national guidelines, have a separate consultation room that can be used for HIV testing and PrEP counseling, and provide the full range of contraceptives to AGYW clients (including EC, OCP, injectables, implants, and condoms). The selection of these pharmacies is currently ongoing.</li>\n</ol>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p>\n <strong><u>PERSONNEL </u></strong></p>\n<p>\n  </p>\n<p>\n <strong>Elizabeth Bukusi, MBchB, MMed, PhD, Principal Investigator                                           </strong></p>\n<p>\n Prof. Bukusi leads the KEMRI research site in Kisumu, Kenya. In addition to her appointment at KEMRI, she is jointly appointed as a Research Associate Professor at the University of Washington. She will provide substantial oversight of all activities that take place at the Kisumu site. As the site Principal Investigator (PI) for the KEMRI team leading activities, she will work closely with the coordinating center and provide oversight of implementation of all research components, including study and intervention design, preparation of data collection instruments, intervention implementation, data collection and management, statistical analyses, as well as fiscal and administrative management of the study.</p>\n<p>\n <strong>Josephine Odoyo, Project Director   KRCHN, MPH                                                              </strong></p>\n<p>\n Josephine Odoyo is a trained nurse by profession and has wide experience in HIV research having coordinated earlier clinical trials at the Kisumu site. She has hands on experience in working in the clinic, training of staff and serves as a quality management officer for KEMRI, responsible for research studies implemented in collaboration with KEMRI. Was involved in among others Pharmacy PrEP Pilot study, the site coordination and execution of Partners PrEP study, Partners Demonstration study and the ongoing Partners Scale up Project.  She will be assisting the Principal investigators in the planning and implementation stage of the project and offering regulatory services ensuring quality is maintained throughout the study implementation.</p>\n<p>\n <strong>Dr. Zachary Kwena, MA, PhD, Qualitative Researcher   -Co-investigator                                                            </strong></p>\n<p>\n Dr. Zachary Kwena will take lead in all aspects of qualitative research of the study. He has a wealth of experience in qualitative work having conducted various qualitative studies in KEMRI.</p>\n<p>\n <strong>TBD, Coordinator                                                               </strong></p>\n<p>\n The coordinator will be responsible for the smooth functioning of the research project, coordinating communications with regulatory boards, staff and investigators, assisting investigators with implementation, planning and problem-solving to ensure project goals are met. The coordinator will be in charge of the day to day running of the site on behalf of the site PI and supervision of site personnel, development of standard operating procedures including preparation and study results dissemination to the relevant regulatory review boards.</p>\n<p>\n <strong>TBD, Study Nurses                                                               </strong></p>\n<p>\n The study nurses will be responsible for guiding of the participants in HIV counselling and testing and administering PrEP study drugs as well as collecting any sample that may be required for further analysis in the lab.</p>\n<p>\n <strong>TBD, Research Assistants</strong></p>\n<p>\n The research assistants will be responsible for mobilizing of the study participants for enrolment and making up follow ups as needed. They will also assist in the qualitative aspects of the study.</p>\n<p>\n <strong>TBD, Laboratory Technician                                                           </strong></p>\n<p>\n The Lab Technologist will be responsible for performing all the lab tests required for the participants, maintaining and charting of the temperature logs in the laboratory, preparing samples for archiving and shipment .and ensuring proper storage is done.</p>\n<p>\n <strong>TBD, Data Manager</strong></p>\n<p>\n The data manager will be responsible for overall management of the study data ensuring all the needed data bases are created and reports generated on timely basis as needed for each data base. Ensuring confidentiality of participants data by creating link log between the participants study ID and participants name which will be kept separately under double locked cabinets</p>\n<p>\n <strong>Dr. Greshon Rota, Pharmacist of Records                                                                     </strong></p>\n<p>\n The Pharmacist of records will be involved in all matters pertaining to the Pharmacy and Poisons Board (PPB) in regard to the registration of the protocol and act as a linkage between the Study and PPB.</p>\n<p>\n <strong>TBD, Qualitative Interviewer                                                           </strong></p>\n<p>\n The Qualitative Interviewer will be responsible for conducting the qualitative interviews of the study and transcribing them. This will be done in the fourth year of the study.</p>\n<p>\n <strong>TBD, Driver Nairobi</strong></p>\n<p>\n The driver based in Nairobi will assist with project driving and delivery needs especially since the PI is based in Nairobi. He will be given a 20% FTE. He will also be responsible for vehicle maintenance and keeping track of vehicle work tickets / logs.</p>\n<p>\n <strong>TBD, Administrator                                                                                 </strong></p>\n<p>\n This administrator will be responsible for assisting in overall planning for the project in liaison with the coordinator, PI and the Chief Finance Administrator and assist in budget preparation, maintaining of proper audit trail for study funds and expenditures, generate monthly invoices, and other financial reports as required in the subcontract. He will also be responsible for the handling and accounting for the field advance given to the project.</p>\n<p>\n <strong>TBD, Office Assistant</strong></p>\n<p>\n The office assistant will be responsible for delivering messages for study needs and ensure that there is a clean environment for working. She will liaise with the administrator in sending and receiving parcels and courier services. She will also clean the office area, washrooms, building surrounding and maintenance of study clinic grounds.</p>\n<p>\n <strong>Rachel Mwakisha-PA to the Principal Investigator                                                   </strong></p>\n<p>\n The PA to the principal Investigator ensures that the calendar for Prof. Bukusi is updated and that her appointments are scheduled efficiently and convenient for the operations of the project.</p>\n<p>\n <strong>Grace Waititu, Finance & Admin Manager-Nairobi                                                         </strong></p>\n<p>\n The Finance & Admin Manager is based in Nairobi. She is instrumental in terms of procurement of equipment and fast tracking of project payments to suppliers. She forwards letters to the headquarters and follow up payments on behalf of the Kisumu site. She also facilitates staff contracts, subcontracts and petty cash advances. In collaboration with the Study Coordinator and the PI she will ensure timely sub-contract agreements; budget preparation and monitoring of line items to ensure they conform to budgets.</p>\n<p>\n <strong>Denis Ochola, HRM </strong></p>\n<p>\n The Human Resource Manager is responsible for the recruitment of personnel and all staff related issues such as disciplinary, medical insurance, salaries and remuneration among others. </p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study is seeking to address persistent drivers of HIV transmission in Africa so as to reduce rate of HIV infection inorder to achieve the UNAIDS “90-90-90” strategy which calls for 90% of HIV-infected individuals to be diagnosed by 2020, 90% of whom will be on anti-retroviral therapy (ART) and 90% of whom will achieve sustained virologic suppression.</span></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_duration2 Years
      • 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_comparatorTenofovir/Emtricitabine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI RCTP Lumumba, Kisumu
      • single_site_physical_addressKEMRI-CMR building, P.O Box 614-40100, Agoi street Lumumba Sub-County Hospital, Kisumu
      • single_site_contact_personJosephine Odoyo
      • single_site_telephone+254733276275
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site1900
      • total_participants_worldwide1900
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB,MMed,PHD
      • investigator1_professional_addressKenya Medical Research Institute PO Box 54840,-00200, Nairobi, Kenya
      • investigator1_telephone+254 733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_Yes
      • number_participants1900
      • notification
      • approval_date23-12-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-10-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonAll reviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2026-02-09 10:15:10
      • created2022-09-09 09:17:55
      • total_sites(null)
      • ecitizen_invoice(null)
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id851
        • application_id1173
        • given_nameELIZABETH
        • middle_name
        • family_nameBUKUSI
        • qualificationMBChB,MMed,PHD
        • professional_addressKenya Medical Research Institute PO Box 54840,-00200, Nairobi, Kenya
        • telephone+254 733617503
        • emailebukusi@rctp.or.ke
        • investigator_roleprincipal
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
    • SiteDetail(array)
      • 0(array)
        • id1314
        • application_id1173
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id605
        • application_id1173
        • sponsorNational Institute of Health
        • sponsor_typeResearch Institution
        • contact_person
        • address9000 Rockville ,PIKE, Bethesda, Maryland 2892
        • telephone_number+1 3014964000
        • fax_number
        • cell_number+1 3014964000
        • email_addressgrantsinfo@nih.gov
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
  • 4(array)
    • Application(array)
      • id927
      • user_id559
      • trial_status_id7
      • abstract_of_study<p>\n The current World Health Organization (WHO) control strategy for Soil-Transmitted Helminths (STH) emphasizes morbidity control through mass drug administration with albendazole or mebendazole, mainly targeting pre-school and school-aged children in endemic areas. Increasing concerns have been raised about the success of these monotherapy strategies: 1) whilst albendazole is still efficacious against <em>Ascaris lumbricoides </em>and hookworm, a low and decreasing efficacy against <em>Trichuris trichiura </em>is observed, and none of these strategies is effective against <em>S. stercoralis</em>; 2) the use of widespread monotherapy could lead to the emergence of albendazole resistance. Modelling studies predict a huge impact on years lived with disability and economic productivity, if these strategies remain unchanged. Ivermectin has shown an enhanced activity against <em>T. trichiura </em>when combined with albendazole, and is considered the drug of choice against strongyloidiasis and other parasitic infections. Adding ivermectin to albendazole would increase efficacy of the interventions, and decrease the possibility of emergence of resistance, as recently suggested by WHO and the Bill and Melinda Gates Foundation reports.</p>\n<p>\n  </p>\n<p>\n The main goal of this project is to develop and test the safety and efficacy of a fixed-dose co-formulation of ivermectin and albendazole against STHs, as a single dose and a three-dose regimen, compared to a single dose of albendazole in a phase III clinical trial. The project will be conducted in schools in Kwale county along the shoreline of the Indian Ocean that has been shown to have high prevalence of <em>Trichiris trichiura</em>. The study population will be school aged children 5-15 years.</p>\n<p>\n  </p>\n<p>\n The project will include capacity building and networking activities. Besides microscopy-based procedures, parasite DNA detecting techniques (PCR) will be used and validated as markers of treatment response. Modelling studies will evaluate the potential impact on transmission and economic benefits of the new treatment regimen. The scientific results will be presented to the scientific community, local governments and other implementation actors and stakeholders. Previous collaborations of members of this consortium developed and tested the safety of a fixed high dose of ivermectin, as a first step towards the fixed- dose combination with albendazole. This consortium integrates complementary expertise in drug development, manufacture and expertise in drug development, manufacture and regulatory processes, expertise in parasitology, veterinary, epidemiology and public health.</p>\n
      • study_title<p align=\"center\">\n <strong>Evaluation of the effectiveness of IVERMECTIN co-formulation vs ALBENDAZOLE for treatment of </strong><strong>for the Treatment of Soil-Transmitted Helminth Infections (<em>Trichuris trichiura</em>, hookworm, <em>Strongyloides stercoralis</em>) in school aged children and Young Adult Subjects (ALIVE Study)</strong></p>\n
      • laymans_summary<p>\n <em>Lay title</em></p>\n<p>\n Evaluation of the effectiveness of IVERMECTIN co-formulation vs. ALBENDAZOLE for treatment of worms</p>\n<p>\n <em>Background</em></p>\n<p>\n Intestinal parasitic worm (STH) are common parasitic infections in Kenya, causing loss of blood and gastrointestinal problems and affecting how a child perfomes at school. The current World Health Organization (WHO) control strategy for worms emphasizes control of sickness cause by worms through mass deworming with albendazole or mebendazole, mainly  pre-school and school-aged children in areas where worms are found in Kenya. However, researchers have raised concerns about the success of these treatment of worms using single drugs as a low and ability of these drugs aganist against whipworms, and the possibilities that mass deworming could lead to the emergence of albendazole failure of the drugs to cure sicknes caused by the worms. Investigating the effectiveness of alternative drugs is important to ensure that these control mass deworming programmes are successful in achieving the target of controlling sickness causes by worms and eventually get rid of worminfection.</p>\n<p>\n <em>What questions are we trying to answer?</em></p>\n<p>\n We want to find out whether combining albendazole and ivermectin into a single drug will be more effective in treating of whipworm infection. The current drugs (albendazole and mebendazole) that are being used for the treatment of whipworm infections are not efficacious; therefore, many children remain infected. We also wish to find out if there is any resistance that can be identified to current deworming drugs that are being used.</p>\n<p>\n <em>Where is the study taking place, how many people does it involve and how are they selected?</em></p>\n<p>\n The study will take place in public primary schools whose village catchment areas are villages along the shores of the Indian Ocean in Kwale county. Approximately 800 children aged between 5-17 years attending one of the participating primary schools who have informed parental consent will be recruited into the study. Children will be selected to be part of the study based on willingness to be part of the research study and being infected with either hookworm, whipworm or threadworm.</p>\n<p>\n <em>What does the study involve for those who are taking part?</em></p>\n<p>\n At the beginning of the study, we will take a stool sample from the children to find out whether or not they are infected with worms. If children do not have worms or only have bilharzia, they will not be included in the study. Children who are infected with hookworm or whipworm or both will be recruited into the study. Once recruited, the children will be randomly assigned into one of the three study arms. Children will then be treated according to the treatment arm in which they were assigned. Twenty-one days after treatment, a stool sample will be collected to check for infection clearance. Study participants will be monitored by study doctors for 3h after treatment for adverse events that may have occurred as a result of treatment. Three and seven days after treatment, children will be revisited at the school premises for adverse event monitoring. In 100 childeren included in the first part of the study blood from a finger prick less than 1ml will be taken to conuct pharmacokinetics assessment at 4, 8, 24, 52 and 78 hours post treatment.</p>\n<p>\n <em>What are the risks and benefits involved in taking part?</em></p>\n<p>\n The drugs are known to show excellent safety profile except for those patients harbouring <em>Loa loa</em> infection(1). In recent studies, descriptions of little visual disturbance were observed. These events were reported to be mild, transient, and of short duration (a few minutes to a few hours). For this reason, in this study, subjects will be observed closely for any immediate risks after study drug administration. We do not think there will be any long-term effects on the participants. The use a combination of albendazole and ivermectin in the proposed combination therapy against STH could offer a solution to several disadvantages in the current strategy in terms of curing of whipworm infection. Participants may experience minor discomfort during the collection of finger-prick blood samples.</p>\n<p>\n <em>How will the study benefit society?</em></p>\n<p>\n The results from this study will offer insight for the effectiveness of a new combination of albendazole and ivermectin with great potential of improving the control of helminth worldwide, with emphasis on whipworms that are currently difficult to treat. Further this results, may increases the possibility of elimination of helminth with the possibility of a more effective drug. Millions of Africans living in areas where whipworm occurs may benefit.</p>\n<p>\n <em>When does the study start and finish?</em></p>\n<p>\n It is estimated that the study will take 18 months from recruitment (January 2021) until completion of data analyses (September 2022).</p>\n<p>\n  </p>\n
      • short_titleALIVE study
      • protocol_noECCT/20/08/02
      • version_noKenya Specific Protocol v1.7, 22nd May 2020
      • date_of_protocol06-08-2020
      • study_drugIVERMECTIN co-formulation vs. ALBENDAZOLE
      • disease_conditionSoil-Transmitted Helminth 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_nameIVERMECTIN co-formulation vs. ALBENDAZOLE
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameALBENDAZOLE
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressstellakepha2005@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_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantCharles Mwandawiro
      • declaration_date117-08-2020
      • declaration_principal_investigatorCharles Mwandawiro
      • declaration_date217-08-2020
      • placebo_presentNo
      • study_objectives<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:633px;\" width=\"633\">\n <thead>\n <tr>\n <th style=\"width:312px;\">\n <p align=\"center\">\n OBJECTIVES</p>\n </th>\n <th style=\"width:321px;\">\n <p align=\"center\">\n ENDPOINTS</p>\n </th>\n </tr>\n <tr>\n <th style=\"width:312px;\">\n <p>\n Phase II componet</p>\n </th>\n <th style=\"width:321px;\">\n <p align=\"center\">\n  </p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>safety</strong> of the Fixed dose combination (FDC) as a single dose or three-dose regimen for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for FDC and FDCx3 (safety).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;height:21px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width:321px;height:21px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To describe the extent of ivermectin exposure in different weight strata.</li>\n <li>\n To evaluate the acceptability/palatability of the FDC 400mg-18mg and 400mg-9mg.</li>\n <li>\n .</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Measurement of the rate of absorption (Cmax), time to reach Cmax (Tmax) and extent of absorption (AUC) of the FDC and FDCx3.</li>\n </ol>\n <ol>\n <li>\n Participant acceptability and palatability evaluation of the FDC 400mg-18mg and 400mg-9mg using the 5 point Likert/numeric rating scale (NRS).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Phase III componet</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC as a single dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400 mg) for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Cure rate (CR) for , <em>T. trichiura</em> 21 days after treatment as determined by microscopy (efficacy <em>T. trichiura</em>).</li>\n </ol>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy </strong>of the FDC as a single dose or 3-day single dose regimen for the treatment of hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the safety of the FDC as a single dose or 3-day dose regimen for the treatment of <em>T. trichiura</em>, hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the performance of PCR in calculating the primary outcome measurement (efficacy) compared to an egg counting method (Kato-Katz).To evaluate the frequency of known ALB resistant alleles in hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> in the three treatment arms before and after treatment.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n CR for hookworm and <em>S. stercoralis</em> 21 days after treatment, as determined by microscopy (efficacy hookworm and <em>S. stercoralis</em>).</li>\n <li>\n Egg reduction rate (ERR) for <em>T. trichiura</em> 21 days after treatment by microscopy.</li>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for ALB, FDC and FDCx3 (safety).</li>\n <li>\n CR for hookworm, <em>T. trichiura</em> and <em>S. stercoralis</em> using PCR.</li>\n <li>\n Parasite burden for hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> by PCR.</li>\n <li>\n Evaluation of genotypic albendazole resistance in the three arms.</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Exploratory</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To assess the efficacy of the FDC against <em>A. lumbricoides</em> in co-infected participants compared to single dose ALB in participants co-infected with this STH.</li>\n <li>\n To describe the efficacy of the FDC in the prevalence of scabies compared to single dose ALB 400 mg.</li>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC in co-infected participants compared to single dose ALB in participants co-infected with STH.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n CR and ERR for <em>A. lumbricoides</em> in co-infected participants.</li>\n </ol>\n <ol>\n <li>\n Prevalence of scabies before and after treatment administration of ALB, FDC and FDCx3.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Specific Phase II/Phase III</p>\n<ol>\n <li>\n Phase II: Positive infection test by microscopy for <em>T. trichiura</em></li>\n <li>\n Phase III: Positive infection test by microscopy for at least one of the following STH: <em>T. trichiura</em> hookworms, and/or larvae of <em>S. stercoralis</em>.</li>\n</ol>\n<p>\n To be applied to Phase II and Phase III</p>\n<ol>\n <li>\n Weight ≥15 Kg.</li>\n <li>\n Male or female, aged 5 to 18 years.</li>\n <li>\n Female subjects who are ≥12 years old must have a negative urine pregnancy test at screening or at the time of randomization.</li>\n <li>\n Ability to take oral medication, willingness to comply with all study procedures.</li>\n <li>\n Parental acceptance to participate in the study by obtaining a signed and dated informed consent form approved by the Regulatory authorities. Verbal assent will also be obtained from children aged 12–18 years.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Intake of ALB, mebendazole and/or IVM or any potentially interacting drug three months prior to the time of randomisation within the previous 3 months before screening.</li>\n <li>\n Residence outside the study area or planning to move away in the four weeks following recruitment.</li>\n <li>\n Epidemiological risk of <em>Loa loa</em> infection.</li>\n <li>\n Serious medical illness, per investigator’s criteria.</li>\n <li>\n Any participant’s condition preventing from the appropriate evaluation and follow-up, as per investigator’s criteria.</li>\n <li>\n Known hypersensitivity to any component of either study treatment.</li>\n <li>\n Positive urine test, pregnant or first week post-partum.</li>\n</ol>\n
      • primary_end_points<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 633px;\" width=\"633\">\n <thead>\n <tr>\n <th style=\"width: 312px;\">\n <p align=\"center\">\n OBJECTIVES</p>\n </th>\n <th style=\"width: 321px;\">\n <p align=\"center\">\n ENDPOINTS</p>\n </th>\n </tr>\n <tr>\n <th style=\"width: 312px;\">\n <p>\n Phase II componet</p>\n </th>\n <th style=\"width: 321px;\">\n <p align=\"center\">\n  </p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>safety</strong> of the Fixed dose combination (FDC) as a single dose or three-dose regimen for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for FDC and FDCx3 (safety).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px; height: 21px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width: 321px; height: 21px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To describe the extent of ivermectin exposure in different weight strata.</li>\n <li>\n To evaluate the acceptability/palatability of the FDC 400mg-18mg and 400mg-9mg.</li>\n <li>\n .</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Measurement of the rate of absorption (Cmax), time to reach Cmax (Tmax) and extent of absorption (AUC) of the FDC and FDCx3.</li>\n </ol>\n <ol>\n <li>\n Participant acceptability and palatability evaluation of the FDC 400mg-18mg and 400mg-9mg using the 5 point Likert/numeric rating scale (NRS).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Phase III componet</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC as a single dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400 mg) for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Cure rate (CR) for , <em>T. trichiura</em> 21 days after treatment as determined by microscopy (efficacy <em>T. trichiura</em>).</li>\n </ol>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy </strong>of the FDC as a single dose or 3-day single dose regimen for the treatment of hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the safety of the FDC as a single dose or 3-day dose regimen for the treatment of <em>T. trichiura</em>, hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the performance of PCR in calculating the primary outcome measurement (efficacy) compared to an egg counting method (Kato-Katz).To evaluate the frequency of known ALB resistant alleles in hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> in the three treatment arms before and after treatment.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n CR for hookworm and <em>S. stercoralis</em> 21 days after treatment, as determined by microscopy (efficacy hookworm and <em>S. stercoralis</em>).</li>\n <li>\n Egg reduction rate (ERR) for <em>T. trichiura</em> 21 days after treatment by microscopy.</li>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for ALB, FDC and FDCx3 (safety).</li>\n <li>\n CR for hookworm, <em>T. trichiura</em> and <em>S. stercoralis</em> using PCR.</li>\n <li>\n Parasite burden for hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> by PCR.</li>\n <li>\n Evaluation of genotypic albendazole resistance in the three arms.</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Exploratory</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To assess the efficacy of the FDC against <em>A. lumbricoides</em> in co-infected participants compared to single dose ALB in participants co-infected with this STH.</li>\n <li>\n To describe the efficacy of the FDC in the prevalence of scabies compared to single dose ALB 400 mg.</li>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC in co-infected participants compared to single dose ALB in participants co-infected with STH.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n CR and ERR for <em>A. lumbricoides</em> in co-infected participants.</li>\n </ol>\n <ol>\n <li>\n Prevalence of scabies before and after treatment administration of ALB, FDC and FDCx3.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n This study will be conducted in primary and secondary schools in Ethiopia, Kenya and Mozambique.</p>\n<p>\n Kenya (phase II and III components)</p>\n<p>\n The study will take place in Kwale county situated on the South coast of Kenya. It borders Tanzania to the South west, Taita taveta County to the West. The total area of the county is approximately 8,270 Km2 with a population of about 760,897.  The southern region of the county is on the shoreline of the Indian Ocean. The county is divided into four sub-counties, twenty wards (and thirty-four (34) locations. The county has 357 public primary schools (class 1-8). Stool and urine sample will be processed at the KEMR-Kwale laboratory.</p>\n<p>\n Ethiopia (phase III component only)</p>\n<p>\n The study will be conducted in the Bahir Dar Zurya woreda (district) in the West Gojam zone of the Amhara region which has an area of 1,443.37 Km2, and a population of 230,000. The district has 36 primary (grade 1 to 8) and 6 secondary (grade 9 and 10) schools. The total number of student population is 49,013 with an average of 1,160 students in each school. Stool and urine samples will be processed at the BDU laboratory by competent laboratory technicians.</p>\n<p>\n Mozambique (phase III component only)</p>\n<p>\n The study will be conducted in the Manhiça district in Southern Mozambique, a peri-urban setting with a predominantly young population. The site runs a Demographic Surveillance System in the area which covers the entire district, with a population of ≈204,000 inhabitants under surveillance, 44% of which are <15 years of age. Every household from the study area is geo-localised with an identification number.  The district has 93 primary and 9 secondary schools with a total student population of 72,829. Stool and urine samples will be processed at the FM-CISM laboratory by competent laboratory technicians.</p>\n<p>\n  </p>\n<p>\n At all sites, community sensitization will be conducted in the villages where the school children live by community health workers. Only children with informed consent and assent will be screened for eligibility and those who are eligible will be enrolled into the study</p>\n
      • other_details_explanation<p>\n The STOP the consortium is coordinated by the <strong>Barcelona Institute for Global Health (ISGlobal)</strong>, in Spain. The institute has greatly contributed to the translation of health research into public health policies, specially, in the fields of NTDs such as Chagas and Yaws disease as well as in Malaria. ISGlobal will coordinate the execution of the Clinical Trial in three sub-Saharan research centres:</p>\n<p>\n 1) The <strong>Centro de Investigação em Saúde da Manhiça (CISM)/Fundação Manhiça (FM) (Mozambique) </strong>has an excellence track record conducting clinical trials with high international standards, and has strong international partnerships, including with the EDCTP Network of Excellence TESA (Trials of Excellence in Southern Africa). Moreover, CISM has a state-of-the-art molecular biology laboratory and the WP5 leader has extensive experience with the performance of molecular diagnostics.</p>\n<p>\n 2) <strong>Bahir Dar University (Ethiopia) </strong>is a public university with a vision of becoming one of the ten premier research universities in Africa.</p>\n<p>\n 3) <strong>Kenyan Medical Research Institute (KEMRI) </strong>is one of the leading institutions in sub-Saharan Africa conducting integrated epidemiological, social, laboratory and clinical research in parallel, with results feeding into local and international health policy. The research facilities in KEMRI include state-of-the-art laboratories, including molecular biology expertise.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n 1) The Centro de Investigação em Saúde da Manhiça (CISM)/Fundação Manhiça (FM) (Mozambique) review Board, submitted awaiting feedback</p>\n<p>\n 2) Bahir Dar University (Ethiopia<strong>) </strong>is a public university with a vision of becoming one of the ten premier research universities in Africa<strong> s</strong>ubmitted awaiting feedbacl</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRegistered Albendazole
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKwale
      • single_site_physical_addressMsambweni, Lunga Lunga
      • single_site_contact_personStella kepha
      • single_site_telephone0721 831303
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listEthiopia and Mozambique
      • data_monitoring_committeeYes
      • total_enrolment_per_site527
      • total_participants_worldwide1223
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • 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_nameStella
      • investigator1_middle_name
      • investigator1_family_nameKepha
      • investigator1_qualificationPhD
      • investigator1_professional_addressKENYA MEDICAL RESEARCH INSTITUTE, Mbagathi Road, P.O. Box 54840, Nairobi, KENYA
      • investigator1_telephone+254-20-2722541
      • investigator1_emailstellakepha2005@yahoo.com
      • organisations_transferred_Yes
      • number_participants126 in Phase II\n401 Phase III\n
      • notification<p>\n N/A</p>\n
      • approval_date12-01-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">Among 1001 </span><span style=\"outline: none !important;\">participants, 636 (63·5%) were infected with </span><span style=\"font-style: italic; outline: none !important;\">T. trichiura</span><span style=\"outline: none !important;\">, 360 (36·0%) with hookworm, and 104 (10·4%) with </span><span style=\"font-style: italic; outline: none !important;\">S. stercoralis</span><span style=\"outline: none !important;\">. A total of 243 </span>participants were allocated to the ALB arm, 381 to the FDCx1, and 377 to the</p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">FDCx3· In both Phase II and III, gastrointestinal symptoms were the most common </span>mild-to-moderate adverse events (AEs) in FDC groups, being resolved within 48 <span style=\"outline: none !important;\">hours without intervention. No serious AEs occurred. For </span><span style=\"font-style: italic; outline: none !important;\">T. trichiura</span><span style=\"outline: none !important;\">, FDCx3 and FDCx1 showed higher CR (97·2% and 82·9%, </span>respectively) than ALB (35·9%). For hookworms, FDCx3 showed a superior CR (95·0%)</p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">than ALB (65·1%), while FDCx1 had a similar CR (79·8%) to ALB. The sample size </span><span style=\"outline: none !important;\">for efficacy evaluation of </span><span style=\"font-style: italic; outline: none !important;\">S. stercoralis</span></p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">was not met.</span></p>\n
      • implication_results<div>\n This Phase II/III study met its primary objectives of demonstrating safety (Phase II) and efficacy (Phase III) of FDC in the enrolled pediatric populations:</div>\n<div>\n ï‚· FDC is more effective for curing T. trichiura infections than ALB, as shown by the significantly higher CRs compared with ALB, and supported by the secondary efficacy endpoint result of significantly higher T. trichiura ERRs compared with ALB.</div>\n<div>\n ï‚· Both of the FDC administration schedules are considered viable dosing strategies, as shown by significantly higher T. trichiura CRs with both the FDC Single Dose and FDC x3 compared with ALB.</div>\n<div>\n ï‚· FDC x3 is more effective for curing hookworm infection than ALB.</div>\n<div>\n ï‚· The efficacy of FDC for curing S. stercoralis was considered inconclusive due to the small sample size of participants positive for this STH.</div>\n<div>\n ï‚· Results of the PPK analysis indicate that the FDC single dose and FDC x3 dosing regimens are adequate for participants over or under 30 kg.</div>\n<div>\n ï‚· FDC single dose and FDC x3 are safe in pediatric populations, as shown by no serious TEAEs and only mild or moderate TEAEs.</div>\n
      • quantity_imported3400
      • quantity_dispensed1116
      • quantity_destroyed2284
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2024-03-25 17:10:18
      • created2020-08-06 14:15:10
      • total_sites(null)
      • ecitizen_invoice(null)
      • ai_content(null)
    • InvestigatorContact(array)
      • 0(array)
        • id573
        • application_id927
        • given_nameCharles
        • middle_name
        • family_nameMwandawiro
        • qualificationPhD
        • professional_addressKENYA MEDICAL RESEARCH INSTITUTE, Mbagathi Road, P.O. Box 54840, Nairobi, KENYA
        • telephone+254-20-2722541
        • emailcmwandawiro@kemri.org
        • investigator_roleprincipal
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
    • SiteDetail(array)
      • 0(array)
        • id802
        • application_id927
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id447
        • application_id927
        • sponsorBARCELONA INSTITUTE FOR GLOBAL HEALTH FOUNDATION
        • sponsor_typeResearch Institution
        • contact_personDr. Nana Aba Williams
        • addressBarcelona (08036), Rosselló, 132
        • telephone_number0034 932275400
        • fax_number
        • cell_number0034 932275400
        • email_addressnana.williams@isglobal.org
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $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

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  • Behavior(array)
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    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
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    • 4CORE/Controller/Component/RequestHandlerComponent.php
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    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
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  • I18n(array)
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    • 1CORE/I18n/L10n.php
  • Log(array)
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    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
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    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
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    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
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    • 6CORE/Event/CakeEvent.php
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    • 8CORE/Core/Object.php
  • Routing(array)
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    • 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)
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    • 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)
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  • Config(array)
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    • 2APP/Config/routes.php
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    • 4APP/Model/InvestigatorContact.php
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    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
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    • Plugin(array)
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    • Plugin(array)
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      • 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)
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    • Behavior(array)
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  • Shim(array)
    • Config(array)
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  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php