Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Summary

Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Secondary objectives: For the first attack: To compare the 2 groups of treatment in terms of: * Day 42 efficacy * Parasitological and fever clearance * Clinical and Biological tolerability * Evolution of gametocyte carriage For attack 2nd and following: To compare the 2 groups of treatment in terms of: * Day 28 and Day 42 clinical and parasitological effectiveness * Clinical and Biological tolerability * Proportion of patients without fever at Day 3 * Proportion of patients without parasites at Day 3 * Evolution of gametocyte carriage * Compliance During the total follow up of the cohort: To compare the 2 groups of treatment in terms of: * Treatment incidence density * Impact of repeated treatment on clinical and biological tolerability * Impact on anaemia * Impact on Hackett score.

Timeline

Start

2008-06

Primary completion

2010-06

Completion

2010-06

Publications

• Yeka A, Lameyre V, Afizi K, Fredrick M, Lukwago R, Kamya MR, Talisuna AO. Efficacy and safety of fixed-dose artesunate-amodiaquine vs. artemether-lumefantrine for repeated treatment of uncomplicated malaria in Ugandan children. PLoS One. 2014 Dec 1;9(12):e113311. doi: 10.1371/journal.pone.0113311. eCollection 2014.

Drugs

Indications