A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00563914
First received: November 22, 2007
Last updated: December 18, 2009
Last verified: December 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: ferroquine (SSR97193) Drug: amodiaquine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 Artesunate) in African Adult Patients With Uncomplicated Malaria |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin [ Time Frame: Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration [ Time Frame: up to 28 days after last dosing ] [ Designated as safety issue: No ]
| Enrollment: | 72 |
| Study Start Date: | October 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ferroquine (SSR97193)
associated with artesunate
|
| Active Comparator: 2 |
Drug: amodiaquine
associated with artesunate
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563914
Locations
| Gabon | |
| Sanofi-Aventis Administrative Office | |
| Lambaréné, Gabon | |
| Kenya | |
| 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 |
More Information
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00563914 History of Changes |
| Other Study ID Numbers: | ACT10420, SSR97193 |
| Study First Received: | November 22, 2007 |
| Last Updated: | December 18, 2009 |
| Health Authority: | Gabon : Comité d'Ethique |
Keywords provided by Sanofi:
|
Malaria |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Amodiaquine Artesunate Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Amebicides |
ClinicalTrials.gov processed this record on May 23, 2013