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

NCT ID: NCT06696144

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2025-07-01

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

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.

Conditions

Multi Drug Resistant Department; Multi Drug Resistant Bacteria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

Skin 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shmuel Harofeh Hospital, Geriatric Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yochai Levy

Hospital deputy director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yochai Levy

Role: CONTACT

yochaylevi@mail.tau.ac.il

972502991516

Nadya Kagansky

Role: CONTACT

batia_nadya.kagansky@moh.gov.il

972506264678

Other Identifiers

SH-109-23

Identifier Type: -

Identifier Source: org_study_id