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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Artemether; Artemisinins; Atovaquone; Atovaquone, proguanil drug combination; Proguanil

Criteria

Inclusion Criteria:

• subjects aged more than 18,

• back from an endemic area with a positive diagnosis of Plasmodium falciparum by microscopic blood (thin and thick film) examination,

• absence of any severe manifestation according to the WHO definition of severe falciparum malaria

EXCLUSION CRITERIA:

• pregnancy,

• ECG abnormality,

• contraindication to treatment,

• previous anti-malaric treatment within 30 days,

• unable to come back at J3, J7 and J28,

• unwilling to consent to participate