drugset / Trial / NCT03893097

Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children

NCT03893097

RandomizedParallel-groupOpen-labelTreatment

Summary

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal. The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

Timeline

Start
2019-10-14
Primary completion
2021-03-04
Completion
2021-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Artesunate Small molecule 4 mg/kg
Subject Mefloquine Unknown 8 mg/kg
Comparator Praziquantel Small molecule 40 mg/kg