Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: October 2007

Interventions

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

Clinical Trial Outcome Measures

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

Participating 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: All

Minimum Age: 6 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dafra Pharma
  • Overall Official(s)
    • Mahamadou S Sissoko, MD, MSPH, Principal Investigator, University of Bamako, Mali

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