- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06696144
Testing Carriage of Resistant Bacteria Using Swabs on Surfaces and Staff in a Complex Nursing Unit for Patients with Resistant Bacteria
Carriage of Resistant Bacteria on Surfaces and Staff in a Complex Nursing Unit for Patients with Resistant Bacteria
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
- To assess whether care team members working in MDR units serve as vectors for infection via skin carriage or personal items.
- Analyze the presence of resistant bacteria on surfaces in both private and shared spaces within the unit to understand infection transmission risks.
Hypotheses
- The MDR unit care team does not broadly carry resistant pathogens on their skin or items and does not significantly transmit infections.
- 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
- Care Team: All staff in Shmuel Harofe's MDR department (doctors, nursing staff, medical, sanitary, and cleaning staff).
- 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
- 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.
- 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).
- 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nadya Kagansky
- Phone Number: 972506264678
- Email: batia_nadya.kagansky@moh.gov.il
Study Contact Backup
- Name: Yochai Levy
- Phone Number: 972502991516
- Email: yochaylevi@mail.tau.ac.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Works in the hospitals MDR department -
Exclusion Criteria: Non
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of positive swabs for CRE and VRE bacteria in care team members working in MDR units.
Time Frame: 3 month
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SH-109-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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