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:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00563914
First received: November 22, 2007
Last updated: December 18, 2009
Last verified: December 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014