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

January 21, 2010 updated by: Kenya Medical Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • KEMRI Centre for Global Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Artesunate+Sulfamethoxypyrazine/pyrimethamine
Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine
Other Names:
  • Co-arinate FDC
Active Comparator: Praziquantel
Drug: Praziquantel
Other Names:
  • Biltricide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the cure rate between the two treatment arms
Time Frame: after 28 days
after 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the proportion of children excreting schistosoma eggs between the two treatment arms
Time Frame: after 28 days
after 28 days
Compare the amount of eggs produced between the two arms
Time Frame: after 28 days
after 28 days
Compare the incidence of clinical and biological adverse events
Time Frame: after 28 days
after 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenya Medical Research Institute

Collaborators

Dafra Pharma

Investigators

  • Study Director: Pauline N Mwinzi, PhD, Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 22, 2010

Last Update Submitted That Met QC Criteria

January 21, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEMRI SSC 1582
  • DRD140 - S6.2008 (Other Identifier: DAFRA Pharma)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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