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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Pyrimethamine
Sulfalene
Artesunate
Praziquantel
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Anthelmintics
Amebicides

ClinicalTrials.gov processed this record on September 30, 2014