CClinicalTrials.gg
Status unknownNCT04709848SSSSBMTUKUpdated Jan 14, 2021

Strongyloides Stercoralis in Bone Marrow Transplant Recipients in the UK

An observational study in Strongyloidiasis and Bone Marrow Transplant Infection, sponsored by Imperial College Healthcare NHS Trust. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Imperial College Healthcare NHS Trust · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
480
Ages
18 Years and older
Sex
All
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Study 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.

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.

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Conditions studied

  • Strongyloidiasis
  • Bone Marrow Transplant Infection

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In context

Strongyloidiasis

21 studies on the registry are indexed under Strongyloidiasis; 3 are open to participants now.

Browse Strongyloidiasis studies →

Lead sponsor

Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Individuals under the care of Haematology at ICHNT

Inclusion criteria

  • Adult patients
  • Under care of Haematology at ICHNT
  • Undergoing BMT Jun 2018 - July 2020 ('pre-screening group') or July 2020 - July 2021 ('screened group')

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years (i.e. managed as paediatric BMT)
  • Previous BMT but no Strongyloides serology result available at the time of data collection
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
480 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pre-screening group

    Individuals undergoing bone marrow transplantation Jun 2018 - July 2020

    Other: None - standard of care

  • Screened group

    Individuals undergoing bone marrow transplantation July 2020 - July 2021

    Other: None - standard of care

Interventions

  • OtherNone - standard of care

    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.

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What researchers measure

Primary outcomes

  1. Strongyloides seropositivity

    Time frame: Baseline

Secondary outcomes

  1. BMT outcome

    Bloodstream infection

    Time frame: Within first 12 months after BMT

  2. BMT outcome

    Respiratory disease

    Time frame: Within first 12 months after BMT

  3. BMT outcome

    Clinically significant diarrhoea

    Time frame: Within first 12 months after BMT

  4. BMT outcome

    CNS infection

    Time frame: Within first 12 months after BMT

  5. BMT outcome

    Graft vs. host disease

    Time frame: Within first 12 months after BMT

  6. BMT outcome

    Length-of-hospital-stay

    Time frame: Within first 12 months after BMT

  7. BMT outcome

    Antibiotic usage (defined daily doses)

    Time frame: Within first 12 months after BMT

  8. BMT outcome

    ICU admission

    Time frame: Within first 12 months after BMT

  9. BMT outcome

    Strongyloides hyperinfection syndrome

    Time frame: Within first 12 months after BMT

  10. BMT outcome

    Mortality

    Time frame: Within first 12 months after BMT

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04709848
Lead sponsor
Imperial College Healthcare NHS Trust
Responsible party
Sponsor
First posted
Jan 14, 2021
Start date
Feb 2021 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jan 14, 2021

Study contacts

Paul Arkell, MBChB
Contact
paul.arkell@nhs.net
02033113311
Frances Davies
Contact
frances.davies1@nhs.net

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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