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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
440
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form: tablets Route of administration: oral
Sanofi-Aventis Investigational Site Number 204001
Cotonou, Benin
Sanofi-Aventis Investigational Site Number 854002
Bobo-Dioulasso, Burkina Faso
Sanofi-Aventis Investigational Site Number 854003
Nouna, Burkina Faso
Sanofi-Aventis Investigational Site Number 854001
Ouagadougou, Burkina Faso
Sanofi-Aventis Investigational Site Number 120001
Yaoundé, Cameroon
Sanofi-Aventis Investigational Site Number 266001
B.P. 118 Lambarene, Gabon
Sanofi-Aventis Investigational Site Number 266002
Libreville, Gabon
Sanofi-Aventis Investigational Site Number 404001
Kilifi, Kenya
Sanofi-Aventis Investigational Site Number 404002
Kisumu, Kenya
Sanofi-Aventis Investigational Site Number 834001
Korogwe, Tanzania
Recrudescent infections at D28 in the groups with ferroquine associated with artesunate. Recrudescence is defined as the recurrence of the same original strain of Plasmodium falciparum regardless of clinical symptoms
Time frame: 4 weeks
Cure rate at Day 28
Time frame: 4 weeks
Parasite Clearance Time (Median).
Time frame: up to 63 days
Fever Clearance Time (Median)
Time frame: up to 63 days
Recrudescent infections at Day 28 in the ferroquine group in monotherapy
Time frame: 4 weeks
Recrudescent infections at Day 63
Time frame: 9 weeks
Adequate Clinical and Parasitological Response (ACPR) at D28
Time frame: 4 weeks
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