Plasmodium Falciparum Infection Clinical Trial
Official title:
Parallel Group, Double-blind, Randomized Study Assessing the Efficacy, Safety and Pharmacokinetic Profiles of Ferroquine Associated With Artesunate and a Single-blind Dose Level of Ferroquine Alone in a 3-day Treatment of Uncomplicated Malaria Due to Plasmodium Falciparum in an Immune Symptomatic African Adult and Pediatric Population.
Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with
no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated
with artesunate - for a 3-day treatment.
Secondary objectives:
- To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment.
- To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine
associated with artesunate and one dose level of ferroquine alone.
- To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse
sampling schedules.
The overall study duration is 64 days, consisting of a screening period (less or equal 1 day), of a 3-day treatment period during which the patient is hospitalized for a maximum of 60 hours, and a follow-up period of 61 days. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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