Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Schistosomiasis Clinical Trial

Official title:

Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424410
• Other study ID #: ERI019729-THRASHER
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: June 12, 2017
• Start date: February 2012
• Est. completion date: November 2014

Study information

• Verified date: June 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

1. lifelong residents of the area

2. have provided at least 2 urine and 2 stool for parasitological examination

3. have given a blood sample before and after each treatment episode

4. be negative for hookworm, Trichuris and Ascaris

Exclusion Criteria:

1. clinical signs of tuberculosis or malaria

2. presenting with fever

3. have had a recent major operation, illness or vaccination

4. have previously received antihelminthic treatment

Related Conditions & MeSH terms

• Schistosomiasis

Locations

Country	Name	City	State
Zimbabwe	National Institutes for Health Research	Harare

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	National Institute for Health Research, United Kingdom, University of Zimbabwe

Country where clinical trial is conducted

Zimbabwe, 

References & Publications (3)

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. — View Citation

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. — View Citation

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/jou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in schistosome-specific and systemic immune responses	Determine the change at 6 weeks post antihelminthic treatment from baseline of schistosome-specific and systemic immune responses	6 weeks
Secondary	Change from baseline in schistosome-specific and systemic immune responses	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.	12 months
Secondary	Change from baseline in schistosome-related morbidity and disease markers	Determine the change in prevalance and magnitude of schistosome-related disease and morbidity markers at 6 weeks from those at baseline.	6 weeks
Secondary	Change from baseline in morbidity and disease markers	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.	12 months

External Links

•   PI's webpage