ACT MALI: Treatment of Malaria Based on Combination Therapies
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Artesunate (Drug); Artesunate + Sulfadoxine-Pyrimethamine (Drug); arthemether + lumefantrine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Valérie Lameyre, Study Director, Affiliation: Sanofi
Summary
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
Clinical Details
Official title: Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical and parasitological cure rateClinical and biological tolerability
Eligibility
Minimum age: 6 Months.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Bougoula, Mali
Additional Information
Starting date: July 2005
Last updated: February 16, 2010
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