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Not yet recruitingNCT06696144Updated Nov 20, 2024

Testing Carriage of Resistant Bacteria Using Swabs on Surfaces and Staff in a Complex Nursing Unit for Patients with Resistant Bacteria

An interventional study of Skin swabs for multi drug resistant bacteria in Multi Drug Resistant Department and Multi Drug Resistant Bacteria, sponsored by Shmuel Harofeh Hospital, Geriatric Medical Center. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Shmuel Harofeh Hospital, Geriatric Medical Center · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Impact of Care Team and Surfaces on the Spread of Resistant Bacteria in a Specialized Complex Nursing Unit for MDR Pathogen Carriers

Background Multi-drug resistant (MDR) bacteria present a severe clinical and epidemiological challenge, typically managed through strict isolation and continuous monitoring. Transmission patterns among long-term care patients remain unclear. At "Shmuel Harofe" Geriatric Hospital, a dedicated MDR skilled care department was established to reduce infection risks in other hospital settings. It's uncertain if patients in this dedicated unit are more exposed to new bacterial colonizations. Contamination may stem from surfaces in rooms or shared spaces, or from the care team.

Research Objectives

  1. To assess whether care team members working in MDR units serve as vectors for infection via skin carriage or personal items.
  2. Analyze the presence of resistant bacteria on surfaces in both private and shared spaces within the unit to understand infection transmission risks.

Hypotheses

  1. The MDR unit care team does not broadly carry resistant pathogens on their skin or items and does not significantly transmit infections.
  2. Surface contamination will be mostly confined to patient rooms, with limited cases on shared surfaces.

Study Design Comparative cross-sectional study with a retrospective cohort component.

Study Population

  1. Care Team: All staff in Shmuel Harofe's MDR department (doctors, nursing staff, medical, sanitary, and cleaning staff).
  2. Surfaces in Departments: Surfaces in MDR patients' rooms and shared areas in the dedicated MDR unit. Surfeces will be revised acording to a test sampels.

Methods and Materials

  1. Staff Sampling: Swabs for CRE and VRE carriage will be collected from hands, facial skin, bags, shoes, cell phones, glasses, and ID badges at the start and end of shifts in the MDR unit.
  2. Surface Sampling: Samples from patient environments (e.g., bed railings, cabinets, light switches) and shared areas (e.g., dining tables, door handles, keyboards, and public phones).
  3. Clinical Data Collection: Epidemiological data (age, gender, functional status, medical background, length of stay) for statistical analysis.

Statistical Analysis:

  • Comparative analysis of bacterial carriage among staff in the MDR unit versus similar wards.
  • Analysis of bacterial carriage frequency on surfaces in the MDR unit versus other wards using logistic regression models to assess the relationship between surface type and contamination levels.

Ethics Informed consent will be obtained from staff for sample collection, with data anonymity preserved.

Potential Contributions The study aims to clarify the roles of care staff and surfaces in transmitting resistant bacteria in dedicated units. Insights into transmission mechanisms may aid in developing improved protocols for patient and staff protection and provide recommendations for hygiene and control procedures in healthcare settings.

02

Conditions studied

  • Multi Drug Resistant Department
  • Multi Drug Resistant Bacteria

Keywords

  • MDR, VRE, CRE, older adults, long term care
03

In context

Lead sponsor

Shmuel Harofeh Hospital, Geriatric Medical Center is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Works in the hospitals MDR department -

Exclusion Criteria: Non

-

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • Diagnostic testSkin swabs for multi drug resistant bacteria

    Swabs from personal items or skin will be obtained from stuff and analyzed to detect CVE or VRE bacteria using Automated Susceptibility Testing

06

What researchers measure

Primary outcomes

  1. Number of positive swabs for CRE and VRE bacteria in care team members working in MDR units.

    Several swabs for VRE and CRE bacteria will be taken from personal items and skin from staff working in a MDR department to access if they serve as vectors for infection via skin carriage or personal items.

    Time frame: 3 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06696144
Lead sponsor
Shmuel Harofeh Hospital, Geriatric Medical Center
Responsible party
Yochai Levy (Hospital deputy director, Shmuel Harofeh Hospital, Geriatric Medical Center) — Principal investigator
First posted
Nov 20, 2024
Start date
Nov 10, 2024 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Nov 20, 2024

Study contacts

Yochai Levy
Contact
yochaylevi@mail.tau.ac.il
972502991516
Nadya Kagansky
Contact
batia_nadya.kagansky@moh.gov.il
972506264678

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 not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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