Study treatments: * Artemether-lumefantrine * Artesunate-amodiaquine * Dihydroartemisinin-piperaquine Location: Maradi, Niger Principal Objective: To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment. Secondary objectives: * To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7 * To assess the incidence of adverse events during the follow-up period; * To measure speed of parasite clearance Methods: In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component. Target population: Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi. Sample size: 221 patients per study treatment; 663 patients in total. Treatment allocation: Random. Outcomes: * Early treatment failure, * Late clinical failure, * Late parasitological failure, * Adequate clinical and parasitological response. Analysis: * Cumulative success or failure rate (Kaplan-Meier analysis). * Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
663
antimalarial ACT
antimalarial ACT
antimalarial ACT
Andoumé Health Centre
Maradi, Maradi Region, Niger
Adequate clinical and parasitological response
Absence of parasitaemia on day 42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
Time frame: 42 days after treatement start
Early treatment failure
* General danger signs or signs of severe malaria on days 1, 2, or 3, in the presence of parasitaemia , or * Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature, or * Parasitaemia on day 3 with axillary temperature ≥ 37.5°C, or * Parasitaemia on day 3 ≥ 25% count on day 0 irrespective of axillary temperature.
Time frame: 1 to 3 days after tratment start
Late clinical failure
* General danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 42 in patients who did not previously meet any of the criteria of early treatment failure; or * Presence of parasitaemia on any day between day 4 and day 42 with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure.
Time frame: from day 4 to day 42 after treatment start
Late Parasitological Failure
\- Presence of parasitaemia on any day between day 7 and day 42 with axillary temperature \< 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.
Time frame: from day 7 to day 42 after treatment start
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