Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)

NCT06243094 | Recruiting

• 1 other identifier: 2023-A01492-43
• Study Type: observational
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ventilator Associated Pneumonia

Keywords

antibiotic; intensive care; guidelines; outcome

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

microbiologically confirmed VAP

patients who meet ATS/IDSA 2005 VAP criteria with microbiological confirmation

Drug: Antibiotic

non microbiologically confirmed VAP

patients who do not meet ATS/IDSA 2005 criteria with microbiological confirmation

Drug: Antibiotic

Interventions

Antibiotic DRUG

All antibiotic therapy characteristics are monitored.

Also known as: antimicrobial therapy

microbiologically confirmed VAP; non microbiologically confirmed VAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Presence of a decision to limit active therapeutic measures at the time of initiating antibiotic therapy
• Organ donor
• 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

Sponsors & Collaborators

• French Society for Intensive Care: lead

Study Sites (1)

Lille university hospital

Lille, Haut de France, 59000, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Anahita Rouzé, MD

  French Intensive Care Society

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahita Rouzé, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 6, 2024
• Study Start: March 12, 2024
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

FR (1)