Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria
- Conditions
- Plasmodium Falciparum Malaria
- Registration Number
- NCT00484900
- Lead Sponsor
- Dafra Pharma
- Brief Summary
The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1390
- age at least 6 months,
- weight at least 5 kg,
- residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
- able to receive oral treatment,
- having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
- suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.
- presence of severe or complicated malaria (WHO 2000),
- severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
- allergic to one of the drugs involved in this study,
- pregnant (reported pregnancy, detected clinically or with the β HCG test),
- use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PCR corrected Adequate Clinical and Parasitological Response on day 28 (follow-up period) Early treatment failure between day 0 and day 3 Late clinical failure between day 4 and day 28 Late parasitological failure between day 7 and day 28
- Secondary Outcome Measures
Name Time Method Parasitic clearance 28 day follow-up period Fever clearance 28 day follow-up period Parasitological re-infection 28 day follow-up period Gametocyte carriage 28 day follow-up period Safety - Adverse events 28 day follow-up period Haemoglobin levels 28 day follow-up period Clinical and biological tolerance (Haemogram + Lever tests) 28 day follow-up period
Trial Locations
- Locations (4)
Cameroon Baptist Convention Clinic of Biyem-Assi
🇨🇲Yaounde, Cameroon
Health centres Rwamagana and Muhima
🇷🇼Kigali, Rwanda
Health centres of Samako, Kolle and Bancoumane
🇲🇱Bamako, Mali
Alhara Alola Health centre
🇸🇩New Halfa, Sudan