NCT05475574

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
954

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Mar 2023Sep 2029

First Submitted

Initial submission to the registry

July 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2029

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2029

Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

6.5 years

First QC Date

July 13, 2022

Last Update Submit

April 25, 2025

Conditions

Infection, Hospital

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Incidence density of acquired ESBLE by species during 6 month period

    during 6 month period

  • The rate of compliance with hand hygiene in health care providers

    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

    Up to 3 months per health department

  • The rate of compliance with personal protective equipment

    Up to 3 months per health department

  • Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS)

    on the day of discharge of the geriatric unit, on average on the 11th day

Study Arms (2)

Before discontinuation of contact precautions for ESBLE

NO INTERVENTION

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

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

Other: Discontinuation of contact precautions for ESBLE

Interventions

Discontinuation of contact precautions for ESBLEOTHER

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

After discontinuation of contact precautions for ESBLE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hôpital Bel Air

Metz, 57085, France

RECRUITING

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Noel BLETTNER, MD

    Mercy Hospital CHR Metz Thionville

    PRINCIPAL INVESTIGATOR

  • Azzeddine AZZEMOU, MD

    Bel Air Hospital CHR Metz Thionville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie RENAUDIN, MD

CONTACT

03 87 55 30 25l.renaudin@chr-metz-thionville.fr

Mathieu LLORENS, MD

CONTACT

03 87 55 38 39m.llorens@chr-metz-thionville.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 27, 2022

Study Start

March 7, 2023

Primary Completion (Estimated)

September 7, 2029

Study Completion (Estimated)

September 21, 2029

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations

FR(1)