Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)

Ventilator Associated Pneumonia Clinical Trial

— PETUNIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243094
• Other study ID #: 2023-A01492-43
• Status: Recruiting
• Start date: March 12, 2024
• Est. completion date: March 12, 2025

Study information

• Verified date: March 2024
• Source: French Society for Intensive Care
• Contact: Anahita Rouzé, MD
• Phone: 0033 3 20 44 40 84
• Email: anahita.rouze[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1060
• Est. completion date: March 12, 2025
• Est. primary completion date: March 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• Antibiotic
All antibiotic therapy characteristics are monitored.

Locations

Country	Name	City	State
France	Lille university hospital	Lille	Haut De France

Sponsors (1)

Lead Sponsor	Collaborator
French Society for Intensive Care

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Total Duration of Appropriate Treatment	Total Duration of Appropriate Treatment for the episode of VAP	ICU stay (up to 28 days)