protocolSection identificationModule nctId: NCT06282315, orgStudyIdInfo id: REALISE, briefTitle: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Insud Pharma, class: INDUSTRY, collaborators name: Ghana Health Services, collaborators name: Kenya Medical Research Institute, collaborators name: Bridges to Development, collaborators name: Sanger Institute, collaborators name: Barcelona Institute for Global Health, collaborators name: European Union, collaborators name: Swiss Confederation, collaborators name: Mundo Sano, descriptionModule briefSummary: An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children., conditionsModule conditions: Soil-Transmitted Helminths, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open-label, randomized at the school level, and each eligible participant within a school will receive only one of the study treatments (ALB or IVM)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is an open study. Participants and the study investigators assessing drug safety will not be blinded to treatment arms. Only the laboratory-based effectiveness measurement will be performed by blinded operators., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: Pre-screening Phase, interventions name: Screenig Phase, interventions name: Randomization, interventions name: Baseline Effectiveness Cohort, interventions name: Day 0 Trial Intervention, interventions name: Active Surveillance (study visit Day 1, Day 2 and Day 7), interventions name: Passive Surveillance, interventions name: Post-Treatment Effectiveness Evaluation, outcomesModule primaryOutcomes measure: AEs and SAEs record of participants treated with FDC compared to ALB., secondaryOutcomes measure: Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 1: Reduction in Strongyloides stercoralis seroprevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 2: Reduction in hookworms and A. lumbricoides prevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 3: Reduction in A. lumbricoides prevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 4: Describe the frequency of scabies before and after the intervention in the two treatment arms., otherOutcomes measure: Exploratory 5: (i) Genetic diversity within and between T. trichiura populations, relative to the FDC or ALB study participants., otherOutcomes measure: Exploratory 5: (ii) Genetic diversity in candidate genes and identification of genes and/or regions in the genome of T. trichiura under selective pressure due to the treatment with FDC and/or ALB;, otherOutcomes measure: Exploratory 5: (iii) Relative abundance of mixed parasite species within and between populations and in response to treatment in the FDC or ALB study participants., otherOutcomes measure: Exploratory 6: (i) Characterization of the microbiome composition at baseline and its implication in MDA effectiveness, otherOutcomes measure: Exploratory 6: (ii) Determine the Impact of MDA with ALB or FDC on the microbiome composition at population level, otherOutcomes measure: Exploratory 6: (iii) Measure the Recovery of the baseline microbiome composition at 11 months post-treatment and its role in reinfection with STH., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ghana Health Service (GHS), city: Accra, country: Ghana, contacts name: Abraham Oduro, PM, role: CONTACT, phone: +233 (0) 50 469 8534, email: aroduro@gmail.com, contacts name: Joseph Opare, PI, role: CONTACT, email: kwadwolarbiopare@gmail.com, geoPoint lat: 5.55602, lon: -0.1969, locations facility: Kenya Medical Research Institution (KEMRI), city: Nairobi, zip: 00200, country: Kenya, contacts name: Benson Singa, PI, role: CONTACT, phone: +254-720018880, email: singabo2008@gmail.com/bsinga@kemri.go.ke, contacts name: Stella Kepha, PM, role: CONTACT, email: stellakepha2005@yahoo.com, geoPoint lat: -1.28333, lon: 36.81667, hasResults: False