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A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01054651
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 22, 2010
Sponsor:
Collaborator:
Dafra Pharma
Information provided by:
Kenya Medical Research Institute

Tracking Information
First Submitted Date  ICMJE January 21, 2010
First Posted Date  ICMJE January 22, 2010
Last Update Posted Date January 22, 2010
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
Compare the cure rate between the two treatment arms [ Time Frame: after 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
  • Compare the proportion of children excreting schistosoma eggs between the two treatment arms [ Time Frame: after 28 days ]
  • Compare the amount of eggs produced between the two arms [ Time Frame: after 28 days ]
  • Compare the incidence of clinical and biological adverse events [ Time Frame: after 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni
Official Title  ICMJE Open-label, Randomized Clinical Trial in Kenya to Determine the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Vs. Praziquantel in the Treatment of S. Mansoni in Children
Brief Summary The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.
Detailed Description Schistosomiasis remains an important parasitic disease in the tropics, including Kenya. In the absence of a vaccine, the major control strategy is the reduction of morbidity by chemotherapy using Praziquantel. Evidence from laboratory studies and field trials continue to show that schistosome worms have developed reduced susceptibility to Praziquantel. These observations indicate the need for research to monitor the trends in efficacy of praziquantel and the need for research to develop novel antischistosomal drugs. Randomized controlled trials have also shown that Artemisinin derivatives (artesunate, artemether) have antischistosomal activity against S. mansoni, S. haematobium and S. japonicum. We propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of 212 school children infected with S.mansoni in Rarieda district in western Kenya. To do this we will screen about 1000 school children by examination of stool for schistosome eggs. Eligible children will be randomized to receive either artesunate plus sulfamethoxypyrazine-pyrimethamine over 3 days or a single dose of Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction.Our study may provide vital information regarding an alternative treatment for S. mansoni infection in children.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schistosoma Mansoni
Intervention  ICMJE
  • Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
    Other Name: Co-arinate FDC
  • Drug: Praziquantel
    Other Name: Biltricide
Study Arms  ICMJE
  • Experimental: Artesunate+Sulfamethoxypyrazine/pyrimethamine
    Intervention: Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
  • Active Comparator: Praziquantel
    Intervention: Drug: Praziquantel
Publications * Obonyo CO, Muok EM, Mwinzi PN. Efficacy of artesunate with sulfalene plus pyrimethamine versus praziquantel for treatment of Schistosoma mansoni in Kenyan children: an open-label randomised controlled trial. Lancet Infect Dis. 2010 Sep;10(9):603-11. doi: 10.1016/S1473-3099(10)70161-4. Epub 2010 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2010)
212
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 6 and 15 years old
  • Study participants appear healthy at enrollment, as assessed by the study clinician
  • Suffering from S. mansoni infection, excreting eggs in stool
  • Residing in Uyoma area, near Lake Victoria
  • Able to receive oral treatment
  • Parent/legal guardian gives informed written consent for the child to participate in the study
  • Child assent to participate in study

Exclusion Criteria:

  • Weighing more than 50 kg
  • Pregnant or lactating at the time of the study
  • Presence of infection with Plasmodium falciparum or other Plasmodium spp.
  • Presence of severe illness, such as cerebral cysticercosis
  • Signs of severe malnutrition (defined as children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
  • Hypersensitivity to As, sulfonamides or PZQ.
  • Use of another anti-malaria or anti-schistosomal drug during the study, or within 28 days before the administration of treatment.
  • Previous participation in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01054651
Other Study ID Numbers  ICMJE KEMRI SSC 1582
DRD140 - S6.2008 ( Other Identifier: DAFRA Pharma )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Charles O. Obonyo, Kenya Medical Research Institute
Study Sponsor  ICMJE Kenya Medical Research Institute
Collaborators  ICMJE Dafra Pharma
Investigators  ICMJE
Study Director: Pauline N Mwinzi, PhD Kenya Medical Research Institute
PRS Account Kenya Medical Research Institute
Verification Date January 2010

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