Overview

Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Status:
Terminated

Trial end date:
2010-11-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 2

Details

Lead Sponsor:

Sanofi

Treatments:

Artemisinins
Artesunate
Ferroquine