Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit (Ger-SP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infection, Hospital
• Intervention / Treatment: Other: Discontinuation of contact precautions for ESBLE

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.

• Study Type: Interventional
• Enrollment (Estimated): 954
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurie RENAUDIN, MD; Phone Number: 0033 03 87 55 30 25; Email: l.renaudin@chr-metz-thionville.fr
• Study Contact Backup: Name: Mathieu LLORENS, MD; Phone Number: 0033 03 87 55 38 39; Email: m.llorens@chr-metz-thionville.fr

Study Locations

• France
  • Metz, France, 57085
    • Recruiting
    • CHR Metz-Thionville/Hôpital Bel Air
    • Contact: Azzedine AZZEMOU, MD; Email: a.azzemou@chr-metz-thionville.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Before discontinuation of contact precautions for ESBLE; Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE
Experimental: After discontinuation of contact precautions for ESBLE; Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE	Other: Discontinuation of contact precautions for ESBLE; Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	during 6 month period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	during 6 month period
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	Up to 3 months per health department
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).	Up to 3 months per health department
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.	Up to 3 months per health department
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.	on the day of discharge of the geriatric unit, on average on the 11th day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Noel BLETTNER, MD, Mercy Hospital CHR Metz Thionville; Principal Investigator: Azzeddine AZZEMOU, MD, Bel Air Hospital CHR Metz Thionville

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): September 7, 2029
• Study Completion (Estimated): September 21, 2029

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: 2021-05-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No