Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

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Brief Title

Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Official Title

Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Brief Summary

      Objective and Hypotheses: This project has the overall objective of implementing and
      evaluating new approaches to reducing the current and future burden of urinary
      schistosomiasis in young children using the antihelminthic drug praziquantel. The
      investigators hypotheses are that (1) praziquantel treatment will be as effective in children
      1 to 5 years of age (who are routinely excluded from schistosomiasis control programmes) as
      it is in older 6-10 year old children and (2) two treatments will be more effective than a
      single treatment, especially in children 1 to 5 years of age.
    

Detailed Description

      This study aims to address the present health inequity by refinement of an existing drug
      regimen to improve the current and future health of pre-school children and infants.
      Praziquantel is cheap, highly efficacious and safe, presenting a realistic opportunity of
      using a pre-existing tool in a modified way to benefit child health and development. The
      study will focus on children aged 1 to 10 years of age, comparing the impact of single vs.
      double treatment with PZQ on the current and future health status of the children. The
      immediate health benefits of PZQ treatment in children aged 6-10 years of age have already
      been documented and therefore by including 6-10 year olds in the proposed study, we can
      determine if the effects of PZQ treatment on health and morbidity measures is age dependent.
      By killing worms PZQ stops the morbidity related to the presence of worms and eggs such as
      anaemia, abdominal pain, diarrhoea and blood in the urine. Therefore the study will
      investigate the immediate health benefits of treating pre-school children and infants.
    


Study Type

Observational


Primary Outcome

Change from baseline in schistosome-specific and systemic immune responses

Secondary Outcome

 Change from baseline in schistosome-specific and systemic immune responses

Condition

Schistosomiasis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

360

Start Date

February 2012

Completion Date

November 2014

Primary Completion Date

July 2014

Eligibility Criteria

        Inclusion Criteria:

          1. lifelong residents of the area

          2. have provided at least 2 urine and 2 stool for parasitological examination

          3. have given a blood sample before and after each treatment episode

          4. be negative for hookworm, Trichuris and Ascaris

        Exclusion Criteria:

          1. clinical signs of tuberculosis or malaria

          2. presenting with fever

          3. have had a recent major operation, illness or vaccination

          4. have previously received antihelminthic treatment
      

Gender

All

Ages

1 Year - 10 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Francisca Mutapi, PhD, , 

Location Countries

Zimbabwe

Location Countries

Zimbabwe

Administrative Informations


NCT ID

NCT01424410

Organization ID

ERI019729-THRASHER


Responsible Party

Principal Investigator

Study Sponsor

University of Edinburgh

Collaborators

 National Institute for Health Research, United Kingdom

Study Sponsor

Francisca Mutapi, PhD, Principal Investigator, University of Edinburgh


Verification Date

June 2017