Malaria Clinical Trial
Official title:
An Open Label, 4 Escalating Dose, Randomized Multicentre Study Evaluating the Safety and Activity of Ferroquine Associated With Artesunate Versus a Positive Calibrator (Amodiaquine Associated With Artesunate) in African Adult Patients With Uncomplicated Malaria
The primary objective is to assess the safety of different doses of ferroquine with
artesunate (AS) in adult African patients with uncomplicated malaria.
The secondary objectives are to assess activity in reducing parasitemia and the
pharmacokinetics of ferroquine and its metabolites.
The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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