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Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

This study has been completed.
Sponsor:
Information provided by:
Dafra Pharma
ClinicalTrials.gov Identifier:
NCT00510159
First received: July 31, 2007
Last updated: January 17, 2008
Last verified: July 2007
History of Changes

July 31, 2007
January 17, 2008
August 2007
October 2007   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00510159 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schistosoma Haematobium
  • Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin
    Other Name: Co-Arinate FDC ®
  • Drug: Praziquantel
Not Provided
Sissoko MS, Dabo A, Traoré H, Diallo M, Traoré B, Konaté D, Niaré B, Diakité M, Kamaté B, Traoré A, Bathily A, Tapily A, Touré OB, Cauwenbergh S, Jansen HF, Doumbo OK. Efficacy of artesunate + sulfamethoxypyrazine/pyrimethamine versus praziquantel in the treatment of Schistosoma haematobium in children. PLoS One. 2009 Oct 5;4(10):e6732.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
December 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Mali
 
NCT00510159
2007/S4
No
Not Provided
Dafra Pharma
Not Provided
Principal Investigator: Mahamadou S Sissoko, MD, MSPH University of Bamako, Mali
Dafra Pharma
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP