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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 rate

Clinical 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

Page last updated: August 20, 2015

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