Treatment of Uncomplicated Malaria in Benin

Study Overview
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Brief Summary
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Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised. The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome. Expected total enrollment: 225 patients Study start: April 2007; expected completion: December 2007

Official Title
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Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study

Conditions
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Uncomplicated Malaria

Intervention / Treatment
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* Drug: sulfadoxine-pyrimethamine
* Drug: artemether-lumefantrine
* Drug: amodiaquine-artesunate coformulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-119 months old fever or history of fever of less than 24 hours p falciparum parasitemia > 1000 trophozoïtes/µL informed consent signed Exclusion Criteria: < 5 kg danger or severity signs of malaria known underlying chronic disease Hb < 5g/dL adequate malaria treatment taken within 3 days before visit

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 119 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>sulfadoxine-pyrimethamine | Drug: sulfadoxine-pyrimethamine<br>* tablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake<br>* Other names: Fansidar;|
| Active Comparator: 2<br>artemether-lumefantrine | Drug: artemether-lumefantrine<br>* tablets 20/120 mg 1 tablet twice daily for 3 days below 15 kg of bodyweight 2 tablets twice daily for 3 days below 24 kg of bodyweight 3 tablets twice daily for 3 days below 35 kg of bodyweight<br>* Other names: coartem;|
| Active Comparator: 3<br>amodiaquine-artesunate coformulation | Drug: amodiaquine-artesunate coformulation<br>* one 25mg/67,5mg tablet, once daily for 3 days below 9 kg one 50/135mg tablet, once daily for 3 days below 18 kg<br>* Other names: coarsucam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness comparisons (PCR corrected) |  | day 14 and day 42 | 
| incidence of adverse events |  | day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, uncomplicated malaria, children, effectiveness