Health Benefits of Repeated Treatment in Pediatric Schistosomiasis

NCT01424410 | Completed

• 1 other identifier: ERI019729-THRASHER
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Schistosomiasis

Keywords

paediatric schistosomiasis morbidity immunology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in schistosome-specific and systemic immune responses

  12 months

• Change from baseline in schistosome-related morbidity and disease markers

  6 weeks

• Change from baseline in morbidity and disease markers

  12 months

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Zimbabwean children

You may qualify if:

• 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

You may not qualify if:

• clinical signs of tuberculosis or malaria
• presenting with fever
• have had a recent major operation, illness or vaccination
• have previously received antihelminthic treatment

Sponsors & Collaborators

• University of Edinburgh: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Zimbabwe: collaborator

Study Sites (1)

National Institutes for Health Research

Harare, Zimbabwe

Location

Related Publications (3)

• 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.

  PMID: 24679476 BACKGROUND

• 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.

  PMID: 28388940 BACKGROUND

• 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.

  PMID: 25793584 RESULT

Related Links

• PI's webpage

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Francisca Mutapi, PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: August 29, 2011
• Study Start: February 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

ZI (1)