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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
  Purpose

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.


Condition Intervention Phase
Schistosoma Haematobium
 Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin
Drug: Praziquantel
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dafra Pharma:

Primary Outcome 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 Outcome 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 ]

Enrollment: 800
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin
    Other Name: Co-Arinate FDC ®
    Drug: Praziquantel
  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510159

Locations
Mali
Djalakorodji, Mali
Sponsors and Collaborators
Dafra Pharma
Investigators
Principal Investigator: Mahamadou S Sissoko, MD, MSPH University of Bamako, Mali
  More Information

No publications provided by Dafra Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00510159     History of Changes
Other Study ID Numbers: 2007/S4
Study First Received: July 31, 2007
Last Updated: January 17, 2008
Health Authority: Mali: Ministry of Health

Keywords provided by Dafra Pharma:
Schistosoma haematobium
Praziquantel
Artesunate + Sulfamethoxypyrazine/pyrimethamine
Randomized double blind placebo controlled clinical trial

Additional relevant MeSH terms:
Schistosomiasis haematobia
Schistosomiasis
Urinary Tract Infections
Infection
Trematode Infections
Helminthiasis
Parasitic Diseases
Urologic Diseases
Praziquantel
Artesunate
Pyrimethamine
Sulfalene
Anthelmintics
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on May 21, 2013