Clinical trial NCT02495909: Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
Official title: Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis
Keywords: paediatric schistosomiasis
morbidity
immunology
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Zimbabwe
First posted: 2015-07-13
Enrollment: 700
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Zimbabwean pre-school children male and female

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 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.

Eligibility 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

Primary outcomes:
measure: Re-infection rates in children treated upon first infection compared to re-infection rates in children treated within 12 months of infection.
timeFrame: 12 months
Secondary outcomes:
measure: Change in immune measures (cytokine and antibody levels) following curative treatment
timeFrame: 24 months from baseline
measure: Compare the change in the gut and urine microbiome structure from baseline in children who become infected and compare to children who remain uninfected.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Prof Takafira Mduluza
Study officials:
affiliation: University of Edinburgh
name: Francisca Mutapi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.