Clinical trial NCT01424410: Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
Official title: Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis
Keywords: paediatric schistosomiasis morbidity immunology
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Zimbabwe
First posted: 2011-08-29
Enrollment: 360
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Zimbabwean children

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 investigators hypotheses are that (1) praziquantel treatment will be as effective in children 1 to 5 years of age (who are routinely excluded from schistosomiasis control programmes) as it is in older 6-10 year old children and (2) two treatments will be more effective than a single treatment, especially in children 1 to 5 years of age.

Detailed description: This study aims to address the present health inequity by refinement of an existing drug regimen 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 1 to 10 years of age, comparing the impact of single vs. double treatment with PZQ on the current and future health status of the children. The immediate health benefits of PZQ treatment in children aged 6-10 years of age have already been documented and therefore by including 6-10 year olds in the proposed study, we can determine if the effects of PZQ treatment on health and morbidity measures is age dependent. 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. Therefore the study will investigate the immediate health benefits of treating pre-school children and infants.

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 hookworm, Trichuris and Ascaris

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

Primary outcomes:
measure: Change from baseline in schistosome-specific and systemic immune responses
timeFrame: 6 weeks
Secondary outcomes:
measure: Change from baseline in schistosome-specific and systemic immune responses
timeFrame: 12 months
measure: Change from baseline in schistosome-related morbidity and disease markers
timeFrame: 6 weeks
measure: Change from baseline in morbidity and disease markers
timeFrame: 12 months
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: National Institutes for Health Research
Study officials:
affiliation: University of Edinburgh
name: Francisca Mutapi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wami WM, Nausch N, Bauer K, Midzi N, Gwisai R, Simmonds P, Mduluza T, Woolhouse M, Mutapi F. Comparing parasitological vs serological determination of Schistosoma haematobium infection prevalence in preschool and primary school-aged children: implications for control programmes. Parasitology. 2014 Dec;141(14):1962-70. doi: 10.1017/S0031182014000213. Epub 2014 Mar 28.
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.
citation: Wami WM, Nausch N, Midzi N, Gwisai R, Mduluza T, Woolhouse M, Mutapi F. Identifying and evaluating field indicators of urogenital schistosomiasis-related morbidity in preschool-aged children. PLoS Negl Trop Dis. 2015 Mar 20;9(3):e0003649. doi: 10.1371/journal.pntd.0003649. eCollection 2015 Mar.