Trial | NCT00484900  Report issue

Title

Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria
Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1390
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.
Study Started
May 31
2006
Study Completion
May 31
2007
Last Update
Mar 26
2008
Estimate

Drug Co-Arinate FDC

Drug Coartem

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.
No Results Posted