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

Centre Hospitalier Régional Metz-Thionville

Status: Enrolling

Conditions: Infection, Hospital

Treatments: Other: Discontinuation of contact precautions for ESBLE

Study type: Interventional

Funder types: Other

Identifiers

NCT05475574

2021-05-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 954 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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954 participants in 2 patient groups

Before discontinuation of contact precautions for ESBLE

No Intervention group

Description:

Implementation of contact precaution in addition to standard precaution for any patient carrying (infected or colonized) ESBLE

After discontinuation of contact precautions for ESBLE

Experimental group

Description:

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

Treatment:

Other: Discontinuation of contact precautions for ESBLE