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Recruiting NCT05475574

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

No phase Interventional Infection, Hospital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discontinuation of contact precautions for ESBLE.
Who it may be relevant to
Registry conditions: Infection, Hospital. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence density of acquired ESBLE [Time frame: during 6 month period]
Secondary outcome measures (5)
  • Incidence density of acquired ESBLE by species during 6 month period [Time frame: during 6 month period]
  • The rate of compliance with hand hygiene in health care providers [Time frame: 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 [Time frame: Up to 3 months per health department]
  • The rate of compliance with personal protective equipment [Time frame: Up to 3 months per health department]
  • Evaluation of satisfaction related to patient care, by self-questionnaire Hospital anxiety and depression scale (HADS) [Time frame: on the day of discharge of the geriatric unit, on average on the 11th day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Prevention

Study locations

France · 1 center
  • CHR Metz-Thionville/Hôpital Bel Air — Metz

Identifiers

NCT: NCT05475574 · 2021-05-CHRMT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗