Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment

October 10, 2018 updated by: University of Edinburgh
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 project aims to (1) determine the operational health benefits of treating schistosome infections early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome structure (species diversity or abundance) is a risk factor for S. haematobium infection or morbidity, and (3) elucidate the factors and underlying mechanisms mediating the reduction/reversal of schistosome-related morbidity and resistance against infection/re-infection in young children.

Study Overview

Status

Completed

Conditions

Detailed Description

This study aims to refine current paediatric treatment of schistosomiasis using the drug Praziquantel (PZQ) 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 3 to 5 years of age, comparing the impact of early vs. later treatment with PZQ on the current and future health status of the children. 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 as well as induced immune responses associated with reduced re-infection rates. Therefore the study will investigate the immediate health benefits of treating pre-school children and infants and the effects of treatment on re-infection rates.

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
      • Harare, Zimbabwe
        • Prof Takafira Mduluza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Zimbabwean pre-school children male and female

Description

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 schistosomes, hookworm, Trichuris and Ascaris
  5. have frequent contact with infective water

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
  5. are infected with any helminths

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-infection rates in children treated upon first infection compared to re-infection rates in children treated within 12 months of infection.
Time Frame: 12 months
Compare re-infection rates in children treated upon first infection vs. those treated within 12 months of infection.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in immune measures (cytokine and antibody levels) following curative treatment
Time Frame: 24 months from baseline
Determine the change at 12 months post antihelminthic treatment from baseline of schistosome-specific (antibody levels) and systemic (cytokine levels) immune responses.
24 months from baseline
Compare the change in the gut and urine microbiome structure from baseline in children who become infected and compare to children who remain uninfected.
Time Frame: 12 months
Determine the change at 12 months in the gut and urine microbiome from baseline in children who become infected and compare this to the change in the same period in age and sex matched children who remain uninfected.
12 months
Determine the treatment-related changes in systemic (cytokine levels) and schistosome- specific ( antibody levels) immune responses in children treated upon first infection vs. those treated within 12 months of infection.
Time Frame: 12 months
Compare the magnitude of change from baseline in schistosome-specific (antibody levels) and systemic (cytokine levels) immune responses in children treated upon first infection to the magnitude of change from baseline in children treated within 12 months of infection at 6 weeks post-treatment
12 months
Reduction of morbidity (UACR and haematuria levels) levels in children treated upon first infection compared to morbidity reduction in children treated within 12 months of infection.
Time Frame: 12 Months
Compare magnitude of the reduction of morbidity (UACR and haematuria levels)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

University of Zimbabwe

Investigators

  • Principal Investigator: Francisca Mutapi, PhD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 27, 2018

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCZ/A/1964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not have ethical permission to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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