drugset / Trial / NCT01150344

Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria

NCT01150344

Phase 4 Completed 317 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated malaria in France, according to the French consensus Conference revised in 2007 on the treatment of imported malaria. The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in the treatment of uncomplicated imported malaria and to determine clinical and parasitological predictive factors associated with a less effectiveness. It's a multicentric, randomised study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients will be included among 15 centres.

Timeline

Start
2010-07
Primary completion
2014-04
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Artemether Small molecule 80 mg Oral
Comparator Atovaquone Small molecule 1000 mg Oral
Comparator LUMEFANTRIN Unknown 480 mg Oral
Comparator Proguanil Small molecule 400 mg Oral

Indications