Malaria Clinical Trial
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.
Objectives: The primary objective of this trial is to study the safety of the combination
methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10
year old children with uncomplicated falciparum malaria in a malaria endemic area compared
to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the
efficacy of MB-AS and MB-AQ.
Population: Children aged 6-10 years with uncomplicated malaria from Nouna town.
Sample size: N= 180 (n=60 for each group).
Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB
combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will
receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The
participants of the comparator group will receive a 3 day regimen of once daily oral AS
(4mg/kg) combined with once daily AQ (10mg/kg).
Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until
day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate
clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological
failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and
parasite clearance time.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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