Clinical Trials Directory

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.