ATAQ EASY: Artesunate + Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
- Conditions
- Malaria
- Registration Number
- NCT00316329
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as a single daily dose, in comparison with administration of Coartem® (artemether+lumefantrine).
Secondary Objectives:
To compare the 3 treatment groups in terms of:
* clinical and parasitological efficacy on D14 and D28 on the global population and on the subpopulation consisting of children aged under 5 years and that for patients aged 5 years and over
* clinical and laboratory safety
* time to parasite clearance
* time to clearance of fever
* changes in gametocytaemia
* impact on anaemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1032
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical and parasitological cure (after PCR correction) on D28 in compliance with WHO classification, for the Coarsucam™ & Coartem® groups
- Secondary Outcome Measures
Name Time Method Clinical & parasitological cure (after PCR correction) on D14 & D28 in the global population & in the two subpopulations-Time to clearance of parasitaemia & fever-Changes in gametocytaemia & anaemia during follow-up- Clinical & laboratory safety
Trial Locations
- Locations (2)
CHU
🇨🇲Yaounde, Cameroon
Centre de santé
🇲🇬Tsiroanomandidy, Madagascar