nctId: NCT06282315 id: REALISE briefTitle: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2026-02 date: 2026-06 date: 2024-02-28 date: 2024-02-28 name: Insud Pharma class: INDUSTRY name: Ghana Health Services name: Kenya Medical Research Institute name: Bridges to Development name: Sanger Institute name: Barcelona Institute for Global Health name: European Union name: Swiss Confederation name: Mundo Sano 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. conditions: Soil-Transmitted Helminths studyType: INTERVENTIONAL phases: PHASE4 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 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 count: 20000 type: ESTIMATED name: Pre-screening Phase name: Screenig Phase name: Randomization name: Baseline Effectiveness Cohort name: Day 0 Trial Intervention name: Active Surveillance (study visit Day 1, Day 2 and Day 7) name: Passive Surveillance name: Post-Treatment Effectiveness Evaluation measure: AEs and SAEs record of participants treated with FDC compared to ALB. measure: Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB. measure: Exploratory 1: Reduction in Strongyloides stercoralis seroprevalence in participants treated with FDC compared with ALB. measure: Exploratory 2: Reduction in hookworms and A. lumbricoides prevalence in participants treated with FDC compared with ALB. measure: Exploratory 3: Reduction in A. lumbricoides prevalence in participants treated with FDC compared with ALB. measure: Exploratory 4: Describe the frequency of scabies before and after the intervention in the two treatment arms. measure: Exploratory 5: (i) Genetic diversity within and between T. trichiura populations, relative to the FDC or ALB study participants. 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; 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. measure: Exploratory 6: (i) Characterization of the microbiome composition at baseline and its implication in MDA effectiveness measure: Exploratory 6: (ii) Determine the Impact of MDA with ALB or FDC on the microbiome composition at population level measure: Exploratory 6: (iii) Measure the Recovery of the baseline microbiome composition at 11 months post-treatment and its role in reinfection with STH. sex: ALL minimumAge: 5 Years maximumAge: 17 Years stdAges: CHILD facility: Ghana Health Service (GHS) city: Accra country: Ghana name: Abraham Oduro, PM role: CONTACT phone: +233 (0) 50 469 8534 email: aroduro@gmail.com name: Joseph Opare, PI role: CONTACT email: kwadwolarbiopare@gmail.com lat: 5.55602 lon: -0.1969 facility: Kenya Medical Research Institution (KEMRI) city: Nairobi zip: 00200 country: Kenya name: Benson Singa, PI role: CONTACT phone: +254-720018880 email: singabo2008@gmail.com/bsinga@kemri.go.ke name: Stella Kepha, PM role: CONTACT email: stellakepha2005@yahoo.com lat: -1.28333 lon: 36.81667 hasResults: False