Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA) (PETUNIA)

Survey on Antibiotic Therapy Practices for Ventilator-Associated Pneumonia in ICU Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Drug: Antibiotic

Detailed Description

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 (Estimated): 1060

Contacts and Locations

• Study Contact: Name: Anahita Rouzé, MD; Phone Number: 0033 3 20 44 40 84; Email: anahita.rouze@chu-lille.fr

Study Locations

• France
  • Haut De France
    • Lille, Haut De France, France, 59000
      • Recruiting
      • Lille University Hospital
      • Contact: Anahita Rouzé, MD
      • Principal Investigator: Anahita Rouzé, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will be ICU patients, undergoing invasive mechanical ventilation > 48h, for whom antibiotic therapy is initiated to treat a suspicion of Ventilator-Associated Pneumonia (VAP).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
microbiologically confirmed VAP; patients who meet ATS/IDSA 2005 VAP criteria with microbiological confirmation	Drug: Antibiotic; All antibiotic therapy characteristics are monitored.; Other Names: antimicrobial therapy
non microbiologically confirmed VAP; patients who do not meet ATS/IDSA 2005 criteria with microbiological confirmation	Drug: Antibiotic; All antibiotic therapy characteristics are monitored.; Other Names: antimicrobial therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	7 days
Total Duration of Appropriate Treatment	Total Duration of Appropriate Treatment for the episode of VAP	ICU stay (up to 28 days)

Collaborators and Investigators

• Sponsor: French Society for Intensive Care
• Investigators: Principal Investigator: Anahita Rouzé, MD, French Intensive Care Society

Study record dates

Study Major Dates

• Study Start (Estimated): March 12, 2024
• Primary Completion (Estimated): March 12, 2025
• Study Completion (Estimated): March 12, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: guidelines; outcome; intensive care; antibiotic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2023-A01492-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No