Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Uncomplicated Malaria in South Kivu, DR Congo
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This will be an open-randomised non-inferiority study to test the hypothesis that the risk of
recurrent parasitaemia after 42 days is not worse in the group receiving the
Artesunate-Amodiaquine (ASAQ) regimen than in the group receiving the Artemether-Lumefantrine
(Coartem®) regimen. Children with uncomplicated malaria meeting the inclusion criteria will
be enrolled (after their parent/caretaker has given informed consent), treated on site with
the drugs under evaluation and followed-up for a period of 42 days. Drugs will be given under
direct supervision, either at the clinic or at home. Follow-up shall consist of a fixed
schedule of clinical and laboratory examinations. Based on clinical and laboratory findings,
children will be classified as therapeutic failures (early or late) or adequate responders.
The proportion of cases experiencing an in vivo therapeutic failure during the follow-up
period will provide an estimate of the efficacy of the drug regimens. A Polymerase Chain
Reaction (PCR) analysis will be carried out to differentiate true recrudescence due to
treatment failure from episodes of re-infection. This proposal is compliant with the latest
WHO recommendations for anti-malarial efficacy monitoring in high, medium or low transmission
zones11.