Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.

Official Title
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Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children

Conditions
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Schistosoma Haematobium

Intervention / Treatment
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* Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin
* Drug: Praziquantel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 6-15 years In good health, according to study doctor Suffering from urinary schistosomiasis, as diagnosed by the presence of S. haematobium eggs in the urine. Residents of Djalakorodji Capable of taking oral medication Written informed consent to participate in the study, obtained from parent or legal guardian. Exclusion Criteria: Weighing more than 50 kg Being pregnant or lactating at the time of the study Patient has a severe concomitant disease, as determined by the clinical examination, such as cerebral cysticercosis, HIV,... Signs of severe malnutrition (children weighing/measuring more than 3 standard deviations or less than 70% of the median standard reference values determined by WHO, or with systemic oedema affecting both feet). Hypersensitivity to As, SMP or PZQ Having taken other antimalarial or antischistosomal medication during the study. Having participated in previous similar studies

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin|nan|
|Drug: Praziquantel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the parasite load between the two treatment arms |  | After 28 days | 
| Compare the amount of eggs produced between the two treatment arms |  | After 28 days | 
| Compare cure rate between the two treatment arms |  | After 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate changes in urine appearance before and after treatment |  | After 28 days | 
| Evaluate changes in haematuria frequency before and after treatment |  | After 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schistosoma haematobium, Praziquantel, Artesunate + Sulfamethoxypyrazine/pyrimethamine, Randomized double blind placebo controlled clinical trial