NCT04709848

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 5, 2021

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Strongyloides seropositivity

    Baseline

Secondary Outcomes (10)

  • BMT outcome

    Within first 12 months after BMT

  • BMT outcome

    Within first 12 months after BMT

  • BMT outcome

    Within first 12 months after BMT

  • BMT outcome

    Within first 12 months after BMT

  • BMT outcome

    Within first 12 months after BMT

  • +5 more secondary outcomes

Study Arms (2)

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

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.

Pre-screening groupScreened group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals under the care of Haematology at ICHNT

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Strongyloidiasis

Condition Hierarchy (Ancestors)

Rhabditida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Central Study Contacts

Paul Arkell, MBChB

CONTACT

Frances Davies

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 14, 2021

Study Start

February 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share