Malaria
Conditions
Brief 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
Interventions
DRUGArtesunate
oad, per os, 3 days of treatment
DRUGArtesunate + Sulfadoxine-Pyrimethamine
oad, per os
DRUGarthemether + lumefantrine
bid, per os. Duration of treatment: 3 days
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and parasitological cure rate | at day 28 |
| Clinical and biological tolerability | During the study period |
Countries
Mali
Outcome results
None listed