Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dafra Pharma
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinine; Artemisinins; Artesunate; Lumefantrine; Pyrimethamine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.