ACT MALI: Treatment of Malaria Based on Combination Therapies

Sanofi780 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

780

Conditions

Malaria

Interventions

ArtesunateDRUG

oad, per os, 3 days of treatment

Artesunate + Sulfadoxine-PyrimethamineDRUG

oad, per os

arthemether + lumefantrineDRUG

bid, per os. Duration of treatment: 3 days

Eligibility

Sex: ALLMin age: 6 Months

Medical Language ↔ Plain English

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 (1)

Sanofi-Aventis Administrative Office

Bougoula, Mali

Outcomes

Primary Outcomes

Clinical and parasitological cure rate

Time frame: at day 28

Clinical and biological tolerability

Time frame: During the study period

Data from ClinicalTrials.gov

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