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Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

This study has been completed.
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Zimbabwe
Information provided by (Responsible Party):
Dr Francisca Mutapi, University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01424410
First received: June 16, 2011
Last updated: June 4, 2015
Last verified: June 2015
History of Changes

June 16, 2011
June 4, 2015
February 2012
July 2014   (final data collection date for primary outcome measure)
Change from baseline in schistosome-specific and systemic immune responses [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Determine the change at 6 weeks post antihelminthic treatment from baseline of schistosome-specific and systemic immune responses
Same as current
Complete list of historical versions of study NCT01424410 on ClinicalTrials.gov Archive Site
  • Change from baseline in schistosome-specific and systemic immune responses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine the change at 12 months post antihelminthic treatment from baseline of schistosome-specific and systemic immune responses. Determine the effects of single and double antihelminthic treatments on these immunological changes.
  • Change from baseline in schistosome-related morbidity and disease markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Determine the change in prevalance and magnitude of schistosome-related disease and morbidity markers at 6 weeks from those at baseline.
  • Change from baseline in morbidity and disease markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determine the change in prevalance and magnitude of schistosome-related disease and morbidity markers at 12 months from those at baseline. Determine the effects of single and double antihelminthic treatments on the disease and morbidity measures.
Same as current
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Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Zimbabwean children
Schistosomiasis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
November 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
1 Year to 10 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Zimbabwe
 
NCT01424410
ERI019729-THRASHER
No
Not Provided
Not Provided
Dr Francisca Mutapi, University of Edinburgh
University of Edinburgh
  • National Institute for Health Research, United Kingdom
  • University of Zimbabwe
Principal Investigator: Francisca Mutapi, PhD University of Edinburgh
University of Edinburgh
June 2015

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