Completed

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

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What is being tested

Artesunate

+ Artesunate + Sulfadoxine-Pyrimethamine

+ arthemether + lumefantrine

Drug
Who is being recruted

Vector Borne Diseases+3

+ Mosquito-Borne Diseases

+ Infections

Over 6 Months
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2005
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2005

Actual date on which the first participant was enrolled.

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

Official TitleAssessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali
NCT00452907
Principal SponsorSanofi
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

780 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 6 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesMosquito-Borne DiseasesInfectionsMalariaParasitic DiseasesProtozoan Infections

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment

Group II

Active Comparator
Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os

Group III

Active Comparator
Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sanofi-Aventis Administrative Office

Bougoula, MaliOpen Sanofi-Aventis Administrative Office in Google Maps
CompletedOne Study Center