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Multi Drug Resistant DepartmentNCT06696144

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

A study testing Skin swabs for multi drug resistant bacteria in people with Multi Drug Resistant Department and Multi Drug Resistant Bacteria, run by Shmuel Harofeh Hospital, Geriatric Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Skin swabs for multi drug resistant bacteria
How many people
20 participants
Where
No sites listed yet
Study dates
10 Nov 2024to 1 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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.

Read more

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.

Being tested
Skin swabs for multi drug resistant bacteria
Keywords
MDR, VRE, CRE, older adults, long term care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skin swabs for multi drug resistant bacteriaDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start10 Nov 2024 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06696144
Sponsor's protocol ID
SH-109-23
Status last verified
Nov 2024
First submitted
4 Nov 2024
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Skin swabs for multi drug resistant bacteria in people with Multi Drug Resistant Department and Multi Drug Resistant Bacteria, run by Shmuel Harofeh Hospital, Geriatric Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yochai Levy (972502991516, yochaylevi@mail.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of positive swabs for CRE and VRE bacteria in care team members working in MDR units. (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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