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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
History of Changes
  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:

MedlinePlus related topics: Malaria
U.S. FDA Resources

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
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
Sulfadoxine-pyrimethamine
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 June 17, 2013