Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Drug: Amodiaquine

Drug: Artesunate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00445796

PM_L_0163

Details and patient eligibility

About

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.

Sex

All

Volunteers

No Healthy Volunteers

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.