Conditions: Malaria, Falciparum
Keywords: P. Falciparum Malaria drug treatment clinical trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 361
Healthy volunteers: no

Brief summary:
The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Azithromycin plus Chloroquine intervention 2: Artemether-lumefantrine
Intervention descriptions: intervention 1: Combination of Azithromycin plus Chloroquine Azithromycin (\~30 mg/kg) + chloroquine (\~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) intervention 2: Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)

Protocol document: