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.
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
- Conditions the study is for
- Multi Drug Resistant Department, Multi Drug Resistant Bacteria
- 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
- 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.
- 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.
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.
- First posted20 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Drug Resistant DepartmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shmuel Harofeh Hospital, Geriatric Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yochai Levy, Shmuel Harofeh Hospital, Geriatric Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carriage of Resistant Bacteria on Surfaces and Staff in a Complex Nursing Unit for Patients with Resistant Bacteria
- ClinicalTrials.gov ID
- NCT06696144
- Acronym / sponsor ID
- SH-109-23
- Keywords
- MDR, VRE, CRE, older adults, long term care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shmuel Harofeh Hospital, Geriatric Medical CenterOther government
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin swabs for multi drug resistant bacteriaSwabs from personal items or skin will be obtained from stuff and analyzed to detect CVE or VRE bacteria using Automated Susceptibility Testing | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.