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

Schistosomiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495909
• Other study ID #: MRCZ/A/1964
• Status: Completed
• Start date: February 2016
• Est. completion date: February 27, 2018

Study information

• Verified date: October 2018
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: February 27, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Schistosomiasis

Locations

Country	Name	City	State
Zimbabwe	Prof Takafira Mduluza	Harare

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	University of Zimbabwe

Country where clinical trial is conducted

Zimbabwe, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in immune measures (cytokine and antibody levels) following curative treatment	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
Secondary	Compare the change in the gut and urine microbiome structure from baseline in children who become infected and compare to children who remain uninfected.	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
Secondary	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.	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
Secondary	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.	Compare magnitude of the reduction of morbidity (UACR and haematuria levels)	12 Months