Clinical trial NCT05475574: Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit
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
Overall status: RECRUITING
Phase: NA
Conditions: Infection, Hospital
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 954
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence density of acquired ESBLE
timeFrame: during 6 month period
Secondary outcomes:
measure: Incidence density of acquired ESBLE by species during 6 month period
timeFrame: during 6 month period
measure: The rate of compliance with hand hygiene in health care providers
timeFrame: Up to 3 months per health department
measure: Evaluation of the barriers to alcohol-based hand rub in case of non-compliance in health care providers
timeFrame: Up to 3 months per health department
measure: The rate of compliance with personal protective equipment
timeFrame: Up to 3 months per health department
measure: Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS)
timeFrame: on the day of discharge of the geriatric unit, on average on the 11th day
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hôpital Bel Air
Study officials:
affiliation: Mercy Hospital CHR Metz Thionville
name: Noel BLETTNER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bel Air Hospital CHR Metz Thionville
name: Azzeddine AZZEMOU, MD
role: PRINCIPAL_INVESTIGATOR
References: