Clinical trial NCT05486130: PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship
Official title: PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on mechanical ventilation for more than 48 hours, with a diagnosis of ventilator-associated lung disease during management according to American Thoracic Society criteria.

Brief summary: Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. Cephalosporinase-producing Enterobacteriaceae have an increasing incidence. Infections in cephalosporinase-producing patients require the use of Cefepime during probabilistic antibiotic therapy, the repeated use of which will lead to a significant risk of selection of resistant mutants. The involvement of cephalosporinases being infrequent, the prediction of their presence during a VAP would make it possible to reduce the consumption of Cefepime and thus to take part in the prevention of selection of bacterial mutants resistant to beta-lactams. The main objective of the research is to determine the risk factors for the involvement of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia (VAP) in hospitalized patients. The secondary objectives are to describe the epidemiology of cephalosporinase-producing enterobacteria in the ICU and to compare the risk factors for the presence of a cephalosporinase-producing germ not without its production being derepressed with those present in situations of cephalosporinase derepression.


Eligibility criteria: Inclusion Criteria:

* Patient 18 years and older
* Patient on mechanical ventilation for more than 48 hours
* Patient with a diagnosis of ventilator-associated lung disease during management according to American Thoracic Society criteria
* French speaking patient

Exclusion Criteria:

* Tracheostomized patient at the time of inclusion
* Limitation of therapies before inclusion in the study
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his/her data for this research

Primary outcomes:
measure: Prevalence of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia
timeFrame: 1 month
Secondary outcomes:
measure: Epidemiology of cephalosporinase-carrying enterobacteria in the ICU
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: François PHILIPPART, MD
role: PRINCIPAL_INVESTIGATOR
References:
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