A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni

Phase 3 Completed 212 enrolled Kenya Medical Research Institute Dafra Pharma · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.

Timeline

Start: 2009-10
Primary completion: 2009-12
Completion: 2009-12

Outcome

Missed primary endpoint

paper 69 patients (65%) were cured in the praziquantel treatment group compared with 15 (14%) in the artesunate with sulfalene plus pyrimethamine treatment group (p<0.0001). PMID 20705516 ↗

Publications

Obonyo CO, Muok EM, Mwinzi PN. Efficacy of artesunate with sulfalene plus pyrimethamine versus praziquantel for treatment of Schistosoma mansoni in Kenyan children: an open-label randomised controlled trial. Lancet Infect Dis. 2010 Sep;10(9):603-11. doi: 10.1016/S1473-3099(10)70161-4. Epub 2010 Aug 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artesunate	Small molecule	100 mg	—
Comparator	Praziquantel	Small molecule	40 mg/kg	—
Subject	pyrimethamine	Small molecule	12.5 mg	—
Subject	sulfalene	Small molecule	250 mg	—