A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal

NCT00540410 Phase 4 COMPLETED

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject. Secondary objectives: For the first attack: To compare the two groups of treatment in terms of: * D14 efficacy * Parasitological and fever clearance * Clinical and biological tolerability * Evolution of gametocyte carriage * Cardiac tolerability (QTc) For the repeated attacks: To compare the two groups of treatment in terms of: * D14 and D28 clinical and parasitological effectiveness (PCR adjusted) * Clinical and biological tolerability * Proportion of patients without fever at D3 * Proportion of patients without parasite at D3 * Compliance * Impact on anaemia During the total follow-up of the cohort: To compare the two groups of treatment in term of: * Treatment incidence density * Impact of repeated treatment on clinical and biological safety * Impact of repeated treatment on hearing capacity

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	366
Start date	2007-09
Completion	2009-02

Conditions

• Malaria

Interventions

• Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)
• Coartem® (arthemether+ lumefantrine)

Primary outcomes

• PCR corrected and uncorrected clinical and parasitological cure rate — at D28 and for the first attack

Countries

Senegal