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

Study Overview
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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.

Official Title
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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

Conditions
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Plasmodium Falciparum Malaria

Intervention / Treatment
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* Drug: Co-Arinate FDC
* Drug: Coartem


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Co-Arinate FDC|nan|
|Drug: Coartem|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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24 hour treatment, Open randomized multi-centre clinical trial in Africa, Uncomplicated P. falciparum malaria, Artemisinin-based Combination Therapy, Artesunate + sulfalene + pyrimethamine, Artemether + lumefantrine