A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00563914

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 I Phase II

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate Amodiaquine Amodiaquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated 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
1: Experimental	Drug: ferroquine (SSR97193) associated with artesunate
2: Active Comparator	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-Aventis

Investigators

Principal Investigator:

Christian Supan, MD

URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	ACT10420, SSR97193
Study First Received:	November 22, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00563914
Health Authority:	Gabon : Comité d'Ethique

Keywords provided by Sanofi-Aventis:

Malaria

Study placed in the following topic categories:

Artesunate
Protozoan Infections
Amodiaquine
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009