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

NCT ID: NCT05475574

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

954 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2029-09-21

Brief Summary

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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

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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.

Conditions

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Infection, Hospital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Before discontinuation of contact precautions for ESBLE

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

Group Type NO_INTERVENTION

No interventions assigned to this group

After discontinuation of contact precautions for ESBLE

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

Group Type EXPERIMENTAL

Discontinuation of contact precautions for ESBLE

Intervention Type OTHER

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

Interventions

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Discontinuation of contact precautions for ESBLE

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

Intervention Type OTHER

Eligibility Criteria

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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


* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noel BLETTNER, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital CHR Metz Thionville

Azzeddine AZZEMOU, MD

Role: PRINCIPAL_INVESTIGATOR

Bel Air Hospital CHR Metz Thionville

Locations

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CHR Metz-Thionville/Hôpital Bel Air

Metz, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurie RENAUDIN, MD

Role: CONTACT

03 87 55 30 25 ext. 0033

Mathieu LLORENS, MD

Role: CONTACT

03 87 55 38 39 ext. 0033

Facility Contacts

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Azzedine AZZEMOU, MD

Role: primary

Other Identifiers

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2021-05-CHRMT

Identifier Type: -

Identifier Source: org_study_id

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