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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Plasmodium Falciparum Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Co-Arinate FDC

Intervention Type DRUG

Coartem

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No