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Completed

NCT Number: NCT00510159

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.

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Key information

Conditions

Schistosoma Haematobium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Helminthiasis Infections Male Urogenital Diseases Parasitic Diseases Schistosomiasis Schistosomiasis haematobia Trematode Infections Urinary Tract Infections Urogenital Diseases Urologic Diseases Vector Borne Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Djalakorodji, Mali

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate+Sulfamethoxypyrazine/pyrimethamin

Drug

Other names: Co-Arinate FDC ®

Praziquantel

Drug

Primary outcomes

  1. Compare the parasite load between the two treatment arms

    Time frame: After 28 days

  2. Compare the amount of eggs produced between the two treatment arms

    Time frame: After 28 days

  3. Compare cure rate between the two treatment arms

    Time frame: After 28 days

Secondary outcomes

  1. Evaluate changes in urine appearance before and after treatment

    Time frame: After 28 days

  2. Evaluate changes in haematuria frequency before and after treatment

    Time frame: After 28 days

Sponsors and collaborators

Lead sponsor

Dafra Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 1, 2007
Registry last updated
Jan 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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