ACT MALI: Treatment of Malaria Based on Combination Therapies

Malaria Clinical Trial

Official title:

Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452907
• Other study ID #: ARTEN_L_00848
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2007
• Last updated: February 16, 2010
• Start date: July 2005
• Est. completion date: June 2007

Study information

• Verified date: February 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: University of Bamako
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artesunate
oad, per os, 3 days of treatment
• Artesunate + Sulfadoxine-Pyrimethamine
oad, per os
• arthemether + lumefantrine
bid, per os. Duration of treatment: 3 days

Locations

Country	Name	City	State
Mali	Sanofi-Aventis Administrative Office	Bougoula

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and parasitological cure rate		at day 28	No
Primary	Clinical and biological tolerability		During the study period	No