PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

Active, not recruiting

• Conditions: Ventilator Associated Pneumonia

• Registration Number: NCT05486130
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-05
• Study Start: 2022-07-18
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Primary Completion: 2022-08-18
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 345

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia	1 month	This outcome corresponds to the the number of ventilator-associated pneumonias involving cephalosporinase-producing enterobacteria.

Secondary Outcome Measures

Name	Time	Method
Epidemiology of cephalosporinase-carrying enterobacteria in the ICU	1 month	This outcome corresponds to the number of pathogens identified in ventilator-associated pneumonia.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France