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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
  Purpose

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 Intervention Phase
Schistosoma Mansoni
Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
Drug: Praziquantel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kenya Medical Research Institute:

Primary Outcome Measures:
  • Compare the cure rate between the two treatment arms [ Time Frame: after 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 212
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artesunate+Sulfamethoxypyrazine/pyrimethamine Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
Other Name: Co-arinate FDC
Active Comparator: Praziquantel Drug: Praziquantel
Other Name: Biltricide

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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01054651

Locations
Kenya
KEMRI Centre for Global Health Research
Kisumu, Kenya
Sponsors and Collaborators
Kenya Medical Research Institute
Dafra Pharma
Investigators
Study Director: Pauline N Mwinzi, PhD Kenya Medical Research Institute
  More Information

No publications provided by Kenya Medical Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Charles O. Obonyo, Kenya Medical Research Institute
ClinicalTrials.gov Identifier: NCT01054651     History of Changes
Other Study ID Numbers: KEMRI SSC 1582, DRD140 - S6.2008
Study First Received: January 21, 2010
Last Updated: January 21, 2010
Health Authority: Kenya: Ethical Review Committee

Keywords provided by Kenya Medical Research Institute:
Schistosoma mansoni
Praziquantel
Artesunate + Sulfamethoxypyrazine/pyrimethamine
Randomized open-label controlled clinical trial

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

ClinicalTrials.gov processed this record on November 25, 2014