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Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis

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ClinicalTrials.gov Identifier: NCT00510159
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : January 18, 2008
Sponsor:
Information provided by:
Dafra Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Schistosoma Haematobium Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin Drug: Praziquantel Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamin
    Other Name: Co-Arinate FDC ®
    Drug: Praziquantel


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510159


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

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
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: January 18, 2008
Last Verified: July 2007

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

Additional relevant MeSH terms:
Artesunate
Artemisinins
Pyrimethamine
Sulfalene
Praziquantel
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anthelmintics
Anti-Infective Agents, Urinary
Renal Agents