Malaria
Conditions
Brief summary
Primary Objective: To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes. Secondary Objective: To compare the clinical safety of the two treatment regimens.
Interventions
DRUGArtesunate
DRUGAmodiaquine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* weighing ≥ 10 kg * residing in the area covered by the investigating centre throughout the entire follow-up period * axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours * Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre
Exclusion criteria
* presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure \< 70 mmHg in adults or \< 50 in children, spontaneous bleeding, inability to sit or stand * serious concomitant disease * allergy to one of the investigational medicinal products * pregnant women or breast-feeding women. * documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical and parasitological cure on Day 14 | — |
| Secondary: incidence and severity of adverse events | — |
Countries
Cameroon, Senegal
Outcome results
None listed