Clinical Trial: A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Art
Brief Summary:
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.
Detailed Summary: 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.
Sponsor: Sanofi
Current Primary Outcome: Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin [ Time Frame: Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Parasite clearance assessed by repeated measurements of parasitemia [ Time Frame: Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28 ]
- Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration [ Time Frame: up to 28 days after last dosing ]
Original Secondary Outcome:
- Parasite clearance assessed by repeated measurements of parasitemia [ Time Frame: Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28 ]
- Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration
Information By: Sanofi
Dates:
Date Received: November 22, 2007
Date Started: October 2007
Date Completion:
Last Updated: December 18, 2009
Last Verified: December 2009
