Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
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.
- EligibilityCriteria: Inclusion Criteria:  Individuals of both sexes that attend the selected schools in the trial areas in Ghana and Kenya that meet the following criteria:  Age: 5 to 17 years old (included). Height: over 90cm. Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation. (In Kenya written assent will be obtained from children 12-17 years old and in Ghana for children 15-17 years old.)  Exclusion Criteria:  Epidemiological risk of being infected by Loa loa. Serious medical illness, per investigator's criteria. Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator's criteria. Known hypersensitivity to any component of either study treatment. Pregnant or first week post-partum, reported by the participant during interview. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 5 Years - MaximumAge: 17 Years - StdAgeList: Child