A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: ferroquine (SSR97193)
associated with artesunate
|
| Active Comparator: 2
|
Drug: amodiaquine
associated with artesunate
|
Outcome Measures
Primary Outcome Measures
- Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin [Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28]
Secondary Outcome Measures
- Parasite clearance assessed by repeated measurements of parasitemia [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 [up to 28 days after last dosing]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body weight between 50 kg and 90 kg with Body Mass Index >18 kg/m²
-
Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours
-
Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL
Exclusion Criteria:
-
Hypersensitivity to quinoleines or artesunate
-
History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information
-
Splenectomized patients
-
Laboratory parameters outside normal ranges
-
Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1&2 antibodies
-
Cardio vascular and Electrocardiogram parameters outside normal values
-
Presence of criteria of complicated malaria
-
Permanent vomiting
-
Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates
-
Positive results on urine drug screen for anti-malaria agents (aminoquinolines)
-
History of drug or alcohol abuse (alcohol consumption > 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol)
-
Intention to use herbal medicine during the study period
-
Immunization injection within last 15 days
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Lambaréné | Gabon | ||
| 2 | Sanofi-Aventis Administrative Office | Nairobi | Kenya |
Sponsors and Collaborators
- Sanofi
Investigators
- Principal Investigator: Christian Supan, MD, URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACT10420
- SSR97193