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

This study has been completed.
Sponsor:
Collaborator:
Dafra Pharma
Information provided by:
Kenya Medical Research Institute
ClinicalTrials.gov Identifier:
NCT01054651
First received: January 21, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 21, 2010
January 21, 2010
October 2009
December 2009   (final data collection date for primary outcome measure)
Compare the cure rate between the two treatment arms [ Time Frame: after 28 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Compare the proportion of children excreting schistosoma eggs between the two treatment arms [ Time Frame: after 28 days ] [ Designated as safety issue: No ]
  • Compare the amount of eggs produced between the two arms [ Time Frame: after 28 days ] [ Designated as safety issue: No ]
  • Compare the incidence of clinical and biological adverse events [ Time Frame: after 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schistosoma Mansoni
  • Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
    Other Name: Co-arinate FDC
  • Drug: Praziquantel
    Other Name: Biltricide
  • Experimental: Artesunate+Sulfamethoxypyrazine/pyrimethamine
    Intervention: Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
  • Active Comparator: Praziquantel
    Intervention: Drug: Praziquantel
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. Epub 2010 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
6 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01054651
KEMRI SSC 1582, DRD140 - S6.2008
No
Dr Charles O. Obonyo, Kenya Medical Research Institute
Kenya Medical Research Institute
Dafra Pharma
Study Director: Pauline N Mwinzi, PhD Kenya Medical Research Institute
Kenya Medical Research Institute
January 2010

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