Overview
Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria
Status:
Completed
Completed
Trial end date:
2015-11-01
2015-11-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Assistance Publique - Hôpitaux de ParisTreatments:
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