Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)

French Society for Intensive Care1,060 enrolled

Overview

The French Society of Intensive Care conducts a comprehensive assessment of current antibiotic therapy practices in critically ill patients suspected of Ventilator-Associated Pneumonia (VAP).

This prospective observational multicenter study will be conducted in intensive care units (ICU) across France and French-speaking regions. The primary objective of this study is to delineate the characteristics of antibiotic treatments administered for a first episode of suspected VAP. Secondary objectives include describing the outcomes of enrolled patients, assessing adherence to European guidelines regarding empirical antibiotic treatment, and identifying factors associated with mortality in patients with microbiologically confirmed VAP.

Study Type

OBSERVATIONAL

Enrollment

1,060

Conditions

Ventilator Associated Pneumonia

Interventions

AntibioticDRUG

All antibiotic therapy characteristics are monitored.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Admission to the ICU * Intubation and duration of invasive mechanical ventilation \> 48 hours * Initiation of new antibiotic therapy to treat a first suspicion of Ventilator-Associated Pneumonia (VAP) Exclusion Criteria: * Presence of a decision to limit active therapeutic measures at the time of initiating antibiotic therapy * Organ donor * Prior inclusion in the study during a previous stay in the intensive care unit (a patient cannot be included multiple times) * Participation in an interventional study focusing on the management of VAP and directly impacting antibiotic therapy practices * Patient and/or family opposition to participation * Lack of affiliation with a social security system

Locations (1)

Lille university hospital

Lille, Haut de France, France

RECRUITING

Outcomes

Primary Outcomes

Characteristics of Initial Antibiotic Treatment

Empirical / guided / directly targeted Monotherapy or combination therapy Monotherapy or combination therapy against resistant GNB Addition of an antibiotic active against Methicillin-Resistant Staphylococcus aureus Molecule(s) and class(es) of antibiotics Time from the onset of suspected VAP to initiation of initial antibiotic treatment Total dose in the first 24 hours for each molecule Administration modalities in the first 24 hours for each molecule Conducting plasma level measurements Appropriate treatment (in patients with microbiologically confirmed VAP) Time from the onset of suspected VAP to initiation of appropriate antibiotic treatment (in patients with microbiologically confirmed VAP) Note for the reviewer: our study is descriptive, and multiple characteristics of initial antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.

Time frame: 3 days

Characteristics of Definitive Antibiotic Treatment (for patients alive at Day 3 only)

Monotherapy or combination therapy Molecule(s) and class(es) of antibiotics Broadening of antibiotic spectrum Discontinuation of all antibiotics (prescribed for VAP treatment) at Day 3 and Day 5 Antibiotic de-escalation at Day 3 and Day 5 by reducing the spectrum of an initial antibiotic or by discontinuing a component of an initial combination of antibiotics Note for the reviewer: our study is descriptive, and multiple characteristics of definite antibiotic treatment have been validated by the institutional review board and methodologist, as a descriptive outcome.

Time frame: 7 days

Total Duration of Appropriate Treatment

Total Duration of Appropriate Treatment for the episode of VAP

Time frame: ICU stay (up to 28 days)

Central Contacts

Anahita Rouzé, MD

CONTACT

0033 3 20 44 40 84 anahita.rouze@chu-lille.fr

Data from ClinicalTrials.gov

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