The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
Centre de Recherche en Sante de Nouna
Nouna, Burkina Faso
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Time frame: 28 days
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)
Time frame: 28 days
Early treatment failure (ETF) rate
Time frame: 28 days
Late clinical failure (LCF) rate at D14 and D28
Time frame: 28 days
Late parasitological failure (LPF) rate at D14 and D28
Time frame: 28 days
Fever clearance time
Time frame: 28 days
Parasite clearance time
Time frame: 28 days
Change in haematocrit after 2,14 and 28 days compared to baseline
Time frame: 28 days
MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose
Time frame: 28 days
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