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

Infection, Hospital Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475574
• Other study ID #: 2021-05-CHRMT
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: March 21, 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Laurie RENAUDIN, MD
• Phone: 03 87 55 30 25
• Email: l.renaudin[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 954
• Est. completion date: March 21, 2025
• Est. primary completion date: March 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cross Infection
• Infection, Hospital

Intervention

Other:
• Discontinuation of contact precautions for ESBLE
Discontinuation of contact precaution : only standard precaution are implemented for any patient carrying (infected or colonized) ESBLE

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hôpital Bel Air	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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