StrongyloidiasisSSSSBMTUKNCT04709848
Strongyloides Stercoralis in Bone Marrow Transplant Recipients in the UK
An observational study of Strongyloidiasis and Bone Marrow Transplant Infection, run by Imperial College Healthcare NHS Trust.
Trial summary
Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America, and can cause severe illness in people with reduced immunity. In the UK, the number of people with Strongyloides is not known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strongyloidiasis, Bone Marrow Transplant Infection
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Dec 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Individuals under the care of Haematology at ICHNT
Who may be able to join
- Adult patients
- Under care of Haematology at ICHNT
- Undergoing BMT Jun 2018 - July 2020 ('pre-screening group') or July 2020 - July 2021 ('screened group')
Who cannot join
- Age < 18 years (i.e. managed as paediatric BMT)
- Previous BMT but no Strongyloides serology result available at the time of data collection
Trial locations and contacts
No sites are listed yet.
Frances Davies contact
About this study
Official title: Seroprevalence and Impact of Screening for Strongyloides Stercoralis in Bone Marrow Transplant Recipients in the UK
Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America, and can cause severe illness in people with reduced immunity. In the UK, the number of people with Strongyloides is not known.
At Imperial College Healthcare NHS Trust (ICHNT) , screening for Stongyloides has recently been introduced as a standard-of-care for all patients undergoing BMT.
In this study, investigators will perform two cross-sectional surveys and report the prevalence of Strongyloides in BMT recipients at ICHNT , as well as comparing clinical outcomes before/after the introduction of routine testing.
Read the detailed description
Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America. Infection can persist for decades, and usually causes mild symptoms. In some people with reduced immune systems (for example those who have bone marrow transplantation), the worms can multiply and cause severe illness and death.
In the UK, the number of people with Strongyloides is not known. However, in many other non-tropical countries, rates are high in immigrant populations (including those who are having bone marrow transplantation, BMT).
At ICHNT, screening for Stongyloides has recently been introduced as a standard-of-care for all patients undergoing BMT. All adult patients with forthcoming BMT at ICHNT will now be screened. Additionally, any patients who have already undergone BMT in the last two years will be screened as part of a look-back exercise as part of their clinical care.
In this study, investigators will perform two cross-sectional surveys. Those who underwent BMT between Jun 2018 - July 2020 will form a 'pre-screening group', and those between July 2020 - July 2021 will form a 'screened group'. It is anticipated that 320 participants will be included in the pre-screening group and 160 in the screened-group (total 480).
Data will be collected retrospectively and the prevalence of Strongyloides in BMT recipients at ICHNT will be reported. Comparison of clinical outcomes between the first and second groups will be undertaken, in order to determine whether the introduction of screening has had an impact.
- Conditions
- Strongyloidiasis, Bone Marrow Transplant Infection
- Being tested
- None - standard of care
- Medical subject headings
- Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - standard of careOther
Observational study only. Pre-screening group were not screened for Strongyloides, as per the standard of care at the time. Screened group were screened for Strongyloides, because the standard of care at our centre changed.
| Study group | Role | What they receive |
|---|---|---|
| Pre-screening group | Individuals undergoing bone marrow transplantation Jun 2018 - July 2020 Receives: Other: None - standard of care | |
| Screened group | Individuals undergoing bone marrow transplantation July 2020 - July 2021 Receives: Other: None - standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strongyloides seropositivity
Measured: Baseline
Secondary outcomes (10)
BMT outcome
Bloodstream infection
Measured: Within first 12 months after BMT
BMT outcome
Respiratory disease
Measured: Within first 12 months after BMT
BMT outcome
Clinically significant diarrhoea
Measured: Within first 12 months after BMT
BMT outcome
CNS infection
Measured: Within first 12 months after BMT
BMT outcome
Graft vs. host disease
Measured: Within first 12 months after BMT
BMT outcome
Length-of-hospital-stay
Measured: Within first 12 months after BMT
BMT outcome
Antibiotic usage (defined daily doses)
Measured: Within first 12 months after BMT
BMT outcome
ICU admission
Measured: Within first 12 months after BMT
BMT outcome
Strongyloides hyperinfection syndrome
Measured: Within first 12 months after BMT
BMT outcome
Mortality
Measured: Within first 12 months after BMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrongyloidiasisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709848
- Sponsor's protocol ID
- 20HH6406
- Acronym
- SSSSBMTUK
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence and Impact of Screening for Strongyloides Stercoralis in Bone Marrow Transplant Recipients in the UK
- ClinicalTrials.gov ID
- NCT04709848
- Acronym / sponsor ID
- SSSSBMTUK / 20HH6406
- Conditions
- Strongyloidiasis, Bone Marrow Transplant Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jan 2021 (actual)
- 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.
Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America, and can cause severe illness in people with reduced immunity. In the UK, the number of people with Strongyloides is not known.
At Imperial College Healthcare NHS Trust (ICHNT) , screening for Stongyloides has recently been introduced as a standard-of-care for all patients undergoing BMT.
In this study, investigators will perform two cross-sectional surveys and report the prevalence of Strongyloides in BMT recipients at ICHNT , as well as comparing clinical outcomes before/after the introduction of routine testing.
Detailed description
Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America. Infection can persist for decades, and usually causes mild symptoms. In some people with reduced immune systems (for example those who have bone marrow transplantation), the worms can multiply and cause severe illness and death.
In the UK, the number of people with Strongyloides is not known. However, in many other non-tropical countries, rates are high in immigrant populations (including those who are having bone marrow transplantation, BMT).
At ICHNT, screening for Stongyloides has recently been introduced as a standard-of-care for all patients undergoing BMT. All adult patients with forthcoming BMT at ICHNT will now be screened. Additionally, any patients who have already undergone BMT in the last two years will be screened as part of a look-back exercise as part of their clinical care.
In this study, investigators will perform two cross-sectional surveys. Those who underwent BMT between Jun 2018 - July 2020 will form a 'pre-screening group', and those between July 2020 - July 2021 will form a 'screened group'. It is anticipated that 320 participants will be included in the pre-screening group and 160 in the screened-group (total 480).
Data will be collected retrospectively and the prevalence of Strongyloides in BMT recipients at ICHNT will be reported. Comparison of clinical outcomes between the first and second groups will be undertaken, in order to determine whether the introduction of screening has had an impact.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-screening group | – | Other: None - standard of careIndividuals undergoing bone marrow transplantation Jun 2018 - July 2020 |
| Screened group | – | Other: None - standard of careIndividuals undergoing bone marrow transplantation July 2020 - July 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals under the care of Haematology at ICHNT
Key inclusion criteria (3 listed)
- Adult patients
- Under care of Haematology at ICHNT
- Undergoing BMT Jun 2018 - July 2020 ('pre-screening group') or July 2020 - July 2021 ('screened group')
Key exclusion criteria (2 listed)
- Age < 18 years (i.e. managed as paediatric BMT)
- Previous BMT but no Strongyloides serology result available at the time of data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - standard of careObservational study only. Pre-screening group were not screened for Strongyloides, as per the standard of care at the time. Screened group were screened for Strongyloides, because the standard of care at our centre changed. | Other | Pre-screening group, Screened group |
Primary outcome
Strongyloides seropositivity
Time frame: Baseline
10 secondary outcomes
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
BMT outcome
Time frame: Within first 12 months after BMT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Frances Davies contact
Questions about this trial
What is this clinical trial studying?
An observational study of Strongyloidiasis and Bone Marrow Transplant Infection, run by Imperial College Healthcare NHS Trust.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Arkell, MBChB (02033113311, paul.arkell@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strongyloides seropositivity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2021.