Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria

Study Overview
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Brief Summary
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This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Detailed Description
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This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Official Title
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Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children

Conditions
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Malaria (Uncomplicated)

Intervention / Treatment
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* Drug: Sulfadoxine-pyrimethamine
* Drug: sulfadoxine-pyrimethamine plus artesunate
* Drug: lumefantrine plus artemether
* Behavioral: Sleeping under insecticide-treated bednet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children < 5 years of age (in one site, patients of all ages are eligible). Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3 Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study Exclusion Criteria: Any evidence of severe malaria that would require hospitalization for treatment. Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs. History of pregnancy or delayed menstrual period Breastfeeding a child less than 8 weeks of age
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxine-pyrimethamine|nan|
|Drug: sulfadoxine-pyrimethamine plus artesunate|nan|
|Drug: lumefantrine plus artemether|nan|
|Behavioral: Sleeping under insecticide-treated bednet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and parasitologic failure rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artsunate, lumefantrine plus artemether, combination therapy