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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin
• Drug: Praziquantel

Primary Measures

• Compare the parasite load between the two treatment arms
  • Time Frame: After 28 days
    
• Compare the amount of eggs produced between the two treatment arms
  • Time Frame: After 28 days
    
• Compare cure rate between the two treatment arms
  • Time Frame: After 28 days
    

Secondary Measures

• Evaluate changes in urine appearance before and after treatment
  • Time Frame: After 28 days
    
• Evaluate changes in haematuria frequency before and after treatment
  • Time Frame: After 28 days
    

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

Lead Sponsor: Dafra Pharma

Overall Clinical Trial Officials and Contacts

Mahamadou S Sissoko, MD, MSPH Principal Investigator University of Bamako, Mali  

Information obtained from ClinicalTrials.gov on October 15, 2008

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