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

• Status: Completed
• Trial end date: 2010-06-01

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.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine