drugset / Trial / NCT01150344
Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |