Clinical Trial: Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
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.
Detailed Summary: 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.
Sponsor: University of Edinburgh
Current Primary Outcome:
- 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.
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
- 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.
- 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
Original Secondary Outcome: Same as current
Information By: University of Edinburgh
Dates:
Date Received: June 9, 2015
Date Started: March 2016
Date Completion: July 2018
Last Updated: July 10, 2015
Last Verified: July 2015
