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

Dafra Pharma

Status and phase

Completed

Phase 3

Conditions

Plasmodium Falciparum Malaria

Treatments

Drug: Co-Arinate FDC

Drug: Coartem

Study type

Interventional

Funder types

Industry

Identifiers

NCT00484900

2005/57/01

Details and patient eligibility

About

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.

Enrollment

1,390 patients

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

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.