Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
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...
Brief Summary
Official Title: “Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: October 2007
Intervention(s) in this Clinical Trial
- Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin
- Drug: Praziquantel
Outcome Measures for this Clinical Trial
Primary Measures
- Compare the parasite load between the two treatment arms
- Time Frame: After 28 days
- Time Frame: After 28 days
- Compare the amount of eggs produced between the two treatment arms
- Time Frame: After 28 days
- Time Frame: After 28 days
- Compare cure rate between the two treatment arms
- Time Frame: After 28 days
- Time Frame: After 28 days
Secondary Measures
- Evaluate changes in urine appearance before and after treatment
- Time Frame: After 28 days
- Time Frame: After 28 days
- Evaluate changes in haematuria frequency before and after treatment
- Time Frame: After 28 days
- Time Frame: After 28 days
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 15 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Dafra Pharma Industry
Overall Clinical Trial Officials and Contacts
Mahamadou S Sissoko, MD, MSPH Principal Investigator University of Bamako, Mali
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00510159
Study ID Number: 2007/S4
ClinicalTrials.gov Identifier: NCT00510159
Health Authority: Mali: Ministry of Health
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00510159
