ACT MALI: Treatment of Malaria Based on Combination Therapies

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00452907
First received: March 27, 2007
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia


Condition Intervention Phase
Malaria
Drug: Artesunate
Drug: Artesunate + Sulfadoxine-Pyrimethamine
Drug: arthemether + lumefantrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical and parasitological cure rate [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
  • Clinical and biological tolerability [ Time Frame: During the study period ] [ Designated as safety issue: No ]

Enrollment: 780
Study Start Date: July 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment
Drug: Artesunate
oad, per os, 3 days of treatment
Active Comparator: 2
Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os
Drug: Artesunate + Sulfadoxine-Pyrimethamine
oad, per os
Active Comparator: 3
Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days
Drug: arthemether + lumefantrine
bid, per os. Duration of treatment: 3 days

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight > 5kg
  • Residence in the investigator site area for the duration of the trial
  • Axillary temperature ≥ 37,5°C at Day 0
  • Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood

Exclusion Criteria:

  • Danger signs or signs of severe malaria
  • Other severe illnesses
  • Allergy to one of the drugs
  • Pregnant women

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: NCT00452907

Locations
Mali
Sanofi-Aventis Administrative Office
Bougoula, Mali
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Lameyre Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00452907     History of Changes
Other Study ID Numbers: ARTEN_L_00848
Study First Received: March 27, 2007
Last Updated: February 16, 2010
Health Authority: Mali: University of Bamako

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Artesunate
Fanasil, pyrimethamine drug combination
Lumefantrine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on August 19, 2014