Trials / Completed
CompletedNCT01424410
Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 360 (actual)
- Sponsor
- University of Edinburgh · Academic / Other
- Sex
- All
- Age
- 1 Year – 10 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2014-07-01
- Completion
- 2014-11-01
- First posted
- 2011-08-29
- Last updated
- 2017-06-14
Locations
1 site across 1 country: Zimbabwe
Source: ClinicalTrials.gov record NCT01424410. Inclusion in this directory is not an endorsement.