Strongyloides Stercoralis in Bone Marrow Transplant Recipients in the UK (SSSSBMTUK)

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.

Study Overview

• Status: Unknown
• Conditions: Strongyloidiasis; Bone Marrow Transplant Infection
• Intervention / Treatment: Other: None - standard of care

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 Type: Observational
• Enrollment (Anticipated): 480

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals under the care of Haematology at ICHNT

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-screening group; Individuals undergoing bone marrow transplantation Jun 2018 - July 2020	Other: None - 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.
Screened group; Individuals undergoing bone marrow transplantation July 2020 - July 2021	Other: None - 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Strongyloides seropositivity	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMT outcome	Bloodstream infection	Within first 12 months after BMT
BMT outcome	Respiratory disease	Within first 12 months after BMT
BMT outcome	Clinically significant diarrhoea	Within first 12 months after BMT
BMT outcome	CNS infection	Within first 12 months after BMT
BMT outcome	Graft vs. host disease	Within first 12 months after BMT
BMT outcome	Length-of-hospital-stay	Within first 12 months after BMT
BMT outcome	Antibiotic usage (defined daily doses)	Within first 12 months after BMT
BMT outcome	ICU admission	Within first 12 months after BMT
BMT outcome	Strongyloides hyperinfection syndrome	Within first 12 months after BMT
BMT outcome	Mortality	Within first 12 months after BMT

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Secernentea Infections; Nematode Infections; Helminthiasis; Rhabditida Infections; Strongyloidiasis
• Other Study ID Numbers: 20HH6406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No