Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Tracking Information
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; (submitted: August 26, 2011)	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
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; (submitted: August 26, 2011)	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.
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
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 *	Wami WM, Nausch N, Bauer K, Midzi N, Gwisai R, Simmonds P, Mduluza T, Woolhouse M, Mutapi F. Comparing parasitological vs serological determination of Schistosoma haematobium infection prevalence in preschool and primary school-aged children: implications for control programmes. Parasitology. 2014 Dec;141(14):1962-70. doi: 10.1017/S0031182014000213. Epub 2014 Mar 28.; Mduluza T, Mutapi F. Putting the treatment of paediatric schistosomiasis into context. Infect Dis Poverty. 2017 Apr 7;6(1):85. doi: 10.1186/s40249-017-0300-8. Review.; Wami WM, Nausch N, Midzi N, Gwisai R, Mduluza T, Woolhouse M, Mutapi F. Identifying and evaluating field indicators of urogenital schistosomiasis-related morbidity in preschool-aged children. PLoS Negl Trop Dis. 2015 Mar 20;9(3):e0003649. doi: 10.1371/journal.pntd.0003649. eCollection 2015 Mar.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: June 4, 2015)	360
Original Estimated Enrollment; (submitted: August 26, 2011)	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: 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
Sex/Gender	Sexes Eligible for Study: All
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	National Institute for Health Research, United Kingdom; University of Zimbabwe
Investigators	Principal Investigator: Francisca Mutapi, PhD University of Edinburgh
PRS Account	University of Edinburgh
Verification Date	June 2017