NCT02495909

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

June 9, 2015

Last Update Submit

October 10, 2018

Conditions

Schistosomiasis

Keywords

paediatric schistosomiasismorbidityimmunology

Outcome Measures

Primary Outcomes (1)

  • Re-infection rates in children treated upon first infection compared to re-infection rates in children treated within 12 months of infection.

    Compare re-infection rates in children treated upon first infection vs. those treated within 12 months of infection.

    12 months

Secondary Outcomes (4)

  • Change in immune measures (cytokine and antibody levels) following curative treatment

    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.

    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.

    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.

    12 Months

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Zimbabwean pre-school children male and female

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

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
  • are infected with any helminths

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Takafira Mduluza

Harare, Zimbabwe

Location

Related Publications (3)

  • Mutapi F, Rujeni N, Bourke C, Mitchell K, Appleby L, Nausch N, Midzi N, Mduluza T. Schistosoma haematobium treatment in 1-5 year old children: safety and efficacy of the antihelminthic drug praziquantel. PLoS Negl Trop Dis. 2011 May;5(5):e1143. doi: 10.1371/journal.pntd.0001143. Epub 2011 May 17.

    PMID: 21610855BACKGROUND

  • Mutapi F. Changing policy and practice in the control of pediatric schistosomiasis. Pediatrics. 2015 Mar;135(3):536-44. doi: 10.1542/peds.2014-3189.

    PMID: 25687146BACKGROUND

  • 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: 28388940BACKGROUND

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector 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
SPONSOR

Study Record Dates

First Submitted

June 9, 2015

First Posted

July 13, 2015

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

February 27, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

We do not have ethical permission to share data

Locations

ZI(1)