Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Summary

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

Timeline

Start

2007-09

Primary completion

2009-02

Completion

2009-02

Publications

• Ndiaye JL, Faye B, Gueye A, Tine R, Ndiaye D, Tchania C, Ndiaye I, Barry A, Cisse B, Lameyre V, Gaye O. Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed-dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial. Malar J. 2011 Aug 12;10:237. doi: 10.1186/1475-2875-10-237.

Drugs

Indications