SchistosomiasisNCT02495909
Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
An observational study of Schistosomiasis, run by University of Edinburgh at 1 site in Zimbabwe.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis
- How many people
- 700 participants
- Where
- 1 siteZimbabwe
- Study dates
- Feb 2016to 27 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Zimbabwean pre-school children male and female
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schistosomiasis
- Keywords
- paediatric schistosomiasis, morbidity, immunology
- Medical subject headings
- Schistosomiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 24 months from baseline
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.
Measured: 12 months
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
Measured: 12 months
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)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completionJan 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zimbabwe
- Responsible party
- Sponsor
- Investigators
- Francisca Mutapi, PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495909
- Sponsor's protocol ID
- MRCZ/A/1964
- Status last verified
- Oct 2018
- First submitted
- 9 Jun 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We do not have ethical permission to share data
Publications
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.
PubMed 21610855Mutapi F. Changing policy and practice in the control of pediatric schistosomiasis. Pediatrics. 2015 Mar;135(3):536-44. doi: 10.1542/peds.2014-3189.
PubMed 25687146Mduluza 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.
PubMed 28388940
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
- ClinicalTrials.gov ID
- NCT02495909
- Acronym / sponsor ID
- MRCZ/A/1964
- Conditions
- Schistosomiasis
- Keywords
- paediatric schistosomiasis, morbidity, immunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Zimbabwe
- Study start
- Feb 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Zimbabwean pre-school children male and female
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
4 secondary outcomes
Change in immune measures (cytokine and antibody levels) following curative treatment
Time frame: 24 months from baseline
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 21610855Mutapi 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.
- Background: PubMed 25687146Mutapi F. Changing policy and practice in the control of pediatric schistosomiasis. Pediatrics. 2015 Mar;135(3):536-44. doi: 10.1542/peds.2014-3189.
- Background: PubMed 28388940Mduluza 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.
- Individual participant dataSharing planned: No. We do not have ethical permission to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisca Mutapi, PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis, run by University of Edinburgh at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495909, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.