Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Conditions
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Schistosomiasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lifelong residents of the area have provided at least 2 urine and 2 stool for parasitological examination have given a blood sample before and after each treatment episode be negative for hookworm, Trichuris and Ascaris Exclusion Criteria: clinical signs of tuberculosis or malaria presenting with fever have had a recent major operation, illness or vaccination have previously received antihelminthic treatment

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in schistosome-specific and systemic immune responses | Determine the change at 6 weeks post antihelminthic treatment from baseline of schistosome-specific and systemic immune responses | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in schistosome-specific and systemic immune responses | 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. | 12 months | 
| Change from baseline in schistosome-related morbidity and disease markers | Determine the change in prevalance and magnitude of schistosome-related disease and morbidity markers at 6 weeks from those at baseline. | 6 weeks | 
| Change from baseline in morbidity and disease markers | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paediatric schistosomiasis morbidity immunology