Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Completed

• Conditions: Schistosomiasis

• Registration Number: NCT01424410
• Lead Sponsor: University of Edinburgh

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 Timeline

• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Study Start: 2012-02
• Primary Completion: 2014-07
• Study Completion: 2014-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in schistosome-specific and systemic immune responses	6 weeks	Determine the change at 6 weeks post antihelminthic treatment from baseline of schistosome-specific and systemic immune responses

Secondary Outcome Measures

Name	Time	Method
Change from baseline in schistosome-specific and systemic immune responses	12 months	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	6 weeks	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	12 months	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.

Trial Locations

Locations (1)

National Institutes for Health Research; 🇿🇼 Harare, Zimbabwe