Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit (Ger-SP)
Primary Purpose
Infection, Hospital
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Discontinuation of contact precautions for ESBLE
Sponsored by
About this trial
This is an interventional prevention trial for Infection, Hospital
Eligibility Criteria
Inclusion Criteria:
- Adult patient (> 18 years old)
- Patient hospitalized in geriatrics during the study period
- Patient of legal age, person of trust, tutor or curator where applicable who has given his free informed and written consent
- Patient affiliated to a social security scheme
Non Inclusion Criteria:
- Patient's refusal to participate in the study
- Patient requiring contact precaution for an indication other than ESBLE (Clostridium difficile, highly resistant to emerging antibiotics (BHRe), etc.) on admission
- Patient under legal protection
- Person deprived of liberty
Exclusion criteria:
- Patient requiring contact precaution for an indication other than ESBL during the patient stay
- Patient's stay period less than 4 days
Sites / Locations
- CHR Metz-Thionville/Hôpital Bel AirRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Before discontinuation of contact precautions for ESBLE
After discontinuation of contact precautions for ESBLE
Arm Description
Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
Outcomes
Primary Outcome Measures
Incidence density of acquired ESBLE
Incidence density of acquired ESBLE in geriatric unit for 1000 days of hospitalization is calculated by dividing the number of acquired ESBLE by the number of days of patients' hospitalization multiplied by 1000 Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample.
The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
Secondary Outcome Measures
Incidence density of acquired ESBLE by species during 6 month period
Incidence density of acquired ESBLE in geriatric unit by species (E. coli versus non-E. coli) for 1000 days of hospitalization. This is calculated by dividing the number of acquired ESBLE by species by the number of days of patients' hospitalization multiplied by 1000.
Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample.
The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
The rate of compliance with hand hygiene in health care providers
The evaluation of the compliance with hygiene measures is calculated in health care providers by dividing the number of hand hygiene moments carried out by the number of opportunities multiplied by 100, according to the World Health Organization (WHO) methodology
Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers
The barriers to alcohol-based hand rub are identified in case of non-compliance, using a Pulpe' friction questionnaire (RéPIAS) where professionals are interviewed about their practices in terms of hand hygiene. For each situation, the professional is also asked how important it is for him to perform hand hygiene in each situation listed above, with a slider to be positioned between 0 (not at all important; worse outcome) and 10 (the most important; better outcome).
The rate of compliance with personal protective equipment
The rate of compliance with the wearing and removal of personal protective equipment throughout patient care, is observed during care related to the management of excreta (changing, putting on or removing a dish basin, use of a basin washer-disinfector).
The rate is calculated by dividing the number of personal protective equipment good caring practices by the number of opportunities multiplied by 100.
Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.
Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Full Information
NCT ID
NCT05475574
First Posted
July 13, 2022
Last Updated
March 8, 2023
Sponsor
Centre Hospitalier Régional Metz-Thionville
1. Study Identification
Unique Protocol Identification Number
NCT05475574
Brief Title
Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit
Acronym
Ger-SP
Official Title
Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae (ESBLE) in a Geriatric Unit: an Interventional Prospective Noninferiority Non-randomized Double-blind Controlled Before and After Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
March 10, 2025 (Anticipated)
Study Completion Date
March 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study.
The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae acquired in geriatric units before and after discontinuing contact precautions.
Detailed Description
Healthcare-associated infections (HAIs) are one of the main causes of morbidity and mortality worldwide. Extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae have become microorganisms frequently found in HAIs, which reduces the therapeutic possibilities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Hospital
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
954 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Before discontinuation of contact precautions for ESBLE
Arm Type
No Intervention
Arm Description
Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE
Arm Title
After discontinuation of contact precautions for ESBLE
Arm Type
Experimental
Arm Description
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
Intervention Type
Other
Intervention Name(s)
Discontinuation of contact precautions for ESBLE
Intervention Description
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE
Primary Outcome Measure Information:
Title
Incidence density of acquired ESBLE
Description
Incidence density of acquired ESBLE in geriatric unit for 1000 days of hospitalization is calculated by dividing the number of acquired ESBLE by the number of days of patients' hospitalization multiplied by 1000 Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample.
The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
Time Frame
during 6 month period
Secondary Outcome Measure Information:
Title
Incidence density of acquired ESBLE by species during 6 month period
Description
Incidence density of acquired ESBLE in geriatric unit by species (E. coli versus non-E. coli) for 1000 days of hospitalization. This is calculated by dividing the number of acquired ESBLE by species by the number of days of patients' hospitalization multiplied by 1000.
Acquisition of ESBLE is defined by a positive sample in patient on discharge day with a negative sample on admission in geriatric unit A positive sample is defined by the presence of at least one ESBLE on a clinical (infection) or screening (colonization) sample.
The hospitalisation number is calculated as the cumulative length of stay of all patients at risk (= negative on admission).
Time Frame
during 6 month period
Title
The rate of compliance with hand hygiene in health care providers
Description
The evaluation of the compliance with hygiene measures is calculated in health care providers by dividing the number of hand hygiene moments carried out by the number of opportunities multiplied by 100, according to the World Health Organization (WHO) methodology
Time Frame
Up to 3 months per health department
Title
Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers
Description
The barriers to alcohol-based hand rub are identified in case of non-compliance, using a Pulpe' friction questionnaire (RéPIAS) where professionals are interviewed about their practices in terms of hand hygiene. For each situation, the professional is also asked how important it is for him to perform hand hygiene in each situation listed above, with a slider to be positioned between 0 (not at all important; worse outcome) and 10 (the most important; better outcome).
Time Frame
Up to 3 months per health department
Title
The rate of compliance with personal protective equipment
Description
The rate of compliance with the wearing and removal of personal protective equipment throughout patient care, is observed during care related to the management of excreta (changing, putting on or removing a dish basin, use of a basin washer-disinfector).
The rate is calculated by dividing the number of personal protective equipment good caring practices by the number of opportunities multiplied by 100.
Time Frame
Up to 3 months per health department
Title
Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS)
Description
The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.
Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Time Frame
on the day of discharge of the geriatric unit, on average on the 11th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient (> 65 years old)
Patient hospitalized in geriatrics during the study period
Free and informed consent obtained from the patient (or his trusted person or legal representative) within 48 hours of its admission at the geriatric unit
Patient affiliated to a social security scheme
Non Inclusion Criteria:
Patient requiring contact precaution for an indication other than ESBLE (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC) on admission
Patient under legal protection
Person deprived of liberty
Exclusion criteria:
Patient requiring contact precaution for an indication other than ESBL during the patient stay (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC)
Patient's stay period less than 4 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie RENAUDIN, MD
Phone
03 87 55 30 25
Ext
0033
Email
l.renaudin@chr-metz-thionville.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu LLORENS, MD
Phone
03 87 55 38 39
Ext
0033
Email
m.llorens@chr-metz-thionville.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel BLETTNER, MD
Organizational Affiliation
Mercy Hospital CHR Metz Thionville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azzeddine AZZEMOU, MD
Organizational Affiliation
Bel Air Hospital CHR Metz Thionville
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Metz-Thionville/Hôpital Bel Air
City
Metz
ZIP/Postal Code
57085
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azzedine AZZEMOU, MD
Email
a.azzemou@chr-metz-thionville.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit
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