The general objectives of the REALISE study are to validate the benefits of the 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.
The clinical trial will have two arms, randomized by school. One will be administered a single dose of the fixed-dose coformulation tablet (albendazole 400mg/ivermectin 9mg for 5-14 children, albendazole 400mg/ivermectin ), while the other, acting as an active control group, will receive a single dose of albendazole 400mg.
The clinical trial will have two arms, randomized by school. One arm will receive a single dose of the fixed-dose coformulation tablet (alb 400mg/ivm 9mg for children between 5 and 14 years old, alb 400mg/ivm 18mg for 15-17s), while the other, acting as an active control group, will receive a single dose of albendazole 400mg.