Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
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ClinicalTrials.gov Identifier: NCT01424410 |
Recruitment Status
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Completed
First Posted
: August 29, 2011
Last Update Posted
: June 14, 2017
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Sponsor:
University of Edinburgh
Collaborators:
National Institute for Health Research, United Kingdom
University of Zimbabwe
Information provided by (Responsible Party):
Dr Francisca Mutapi, University of Edinburgh
Tracking Information | ||||
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First Submitted Date | June 16, 2011 | |||
First Posted Date | August 29, 2011 | |||
Last Update Posted Date | June 14, 2017 | |||
Study Start Date | February 2012 | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01424410 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Health Benefits of Repeated Treatment in Pediatric Schistosomiasis | |||
Official Title | Health Benefits of Repeated Treatment in Pediatric Schistosomiasis | |||
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 Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Zimbabwean children | |||
Condition | Schistosomiasis | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
360 | |||
Original Estimated Enrollment |
700 | |||
Actual Study Completion Date | November 2014 | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Year to 10 Years (Child) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Zimbabwe | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01424410 | |||
Other Study ID Numbers | ERI019729-THRASHER | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Dr Francisca Mutapi, University of Edinburgh | |||
Study Sponsor | University of Edinburgh | |||
Collaborators |
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Investigators |
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PRS Account | University of Edinburgh | |||
Verification Date | June 2017 |