Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
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ClinicalTrials.gov Identifier: NCT01424410
Recruitment Status :
First Posted : August 29, 2011
Last Update Posted : June 14, 2017
University of Edinburgh
National Institute for Health Research, United Kingdom
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 or disease
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.
Change from baseline in schistosome-specific and systemic immune responses [ Time Frame: 6 weeks ]
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 ]
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 ]
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 ]
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.
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Ages Eligible for Study:
1 Year to 10 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
clinical signs of tuberculosis or malaria
presenting with fever
have had a recent major operation, illness or vaccination