NCT06696144

Brief 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

  • 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.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

November 4, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

November 10, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 4, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

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

Outcome Measures

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.

    3 month

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital deputy director

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 20, 2024

Study Start

November 10, 2024

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share