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Completed

NCT Number: NCT02495909

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

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.

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Key information

Conditions

Schistosomiasis Helminthiasis Infections Parasitic Diseases Trematode Infections Vector Borne Diseases

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof Takafira Mduluza

Harare, Zimbabwe

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

    Time frame: 12 months

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

Secondary outcomes

  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

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • University of Zimbabwe

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2015
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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