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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. Identifier: NCT01054651
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 22, 2010
Dafra Pharma
Information provided by:
Kenya Medical Research Institute

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.

Condition or disease Intervention/treatment Phase
Schistosoma Mansoni Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine Drug: Praziquantel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Artesunate+Sulfamethoxypyrazine/pyrimethamine Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
Other Name: Co-arinate FDC

Active Comparator: Praziquantel Drug: Praziquantel
Other Name: Biltricide

Primary Outcome Measures :
  1. Compare the cure rate between the two treatment arms [ Time Frame: after 28 days ]

Secondary Outcome Measures :
  1. Compare the proportion of children excreting schistosoma eggs between the two treatment arms [ Time Frame: after 28 days ]
  2. Compare the amount of eggs produced between the two arms [ Time Frame: after 28 days ]
  3. Compare the incidence of clinical and biological adverse events [ Time Frame: after 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01054651

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KEMRI Centre for Global Health Research
Kisumu, Kenya
Sponsors and Collaborators
Kenya Medical Research Institute
Dafra Pharma
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Study Director: Pauline N Mwinzi, PhD Kenya Medical Research Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Charles O. Obonyo, Kenya Medical Research Institute Identifier: NCT01054651    
Other Study ID Numbers: KEMRI SSC 1582
DRD140 - S6.2008 ( Other Identifier: DAFRA Pharma )
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010
Keywords provided by Kenya Medical Research Institute:
Schistosoma mansoni
Artesunate + Sulfamethoxypyrazine/pyrimethamine
Randomized open-label controlled clinical trial
Additional relevant MeSH terms:
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Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents