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Trial record 2 of 53 for:    "Schistosomiasis"

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

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ClinicalTrials.gov Identifier: NCT02495909
Recruitment Status : Active, not recruiting
First Posted : July 13, 2015
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
University of Zimbabwe
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease
Schistosomiasis

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
Actual Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
Study Start Date : February 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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) measures levels in children treated upon first infection vs. the magnitude of reduction of morbidity levels in children treated within 12 months of infection.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Zimbabwean pre-school children male and female
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495909


Locations
Zimbabwe
Prof Takafira Mduluza
Harare, Zimbabwe
Sponsors and Collaborators
University of Edinburgh
University of Zimbabwe
Investigators
Principal Investigator: Francisca Mutapi, PhD University of Edinburgh

Publications:
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02495909     History of Changes
Other Study ID Numbers: MRCZ/A/1964
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not have ethical permission to share data

Keywords provided by University of Edinburgh:
paediatric schistosomiasis
morbidity
immunology

Additional relevant MeSH terms:
Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents