Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

This study is ongoing, but not recruiting participants.
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: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition
Schistosomiasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 700
Study Start Date: February 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Zimbabwean children

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
  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: NCT01424410

Locations
Zimbabwe
National Institutes for Health Research
Harare, Zimbabwe
Sponsors and Collaborators
University of Edinburgh
National Institute for Health Research, United Kingdom
University of Zimbabwe
Investigators
Principal Investigator: Francisca Mutapi, PhD University of Edinburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Francisca Mutapi, Dr, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01424410     History of Changes
Other Study ID Numbers: ERI019729-THRASHER
Study First Received: June 16, 2011
Last Updated: March 7, 2014
Health Authority: Zimbabwe: Medical Research Council

Keywords provided by University of Edinburgh:
paediatric schistosomiasis morbidity immunology

Additional relevant MeSH terms:
Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on August 21, 2014