An observational study in Ventilator Associated Pneumonia, sponsored by French Society for Intensive Care. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by French Society for Intensive Care · Observational
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.
2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.
This study's planned enrollment of 1,060 is above the median of 201 across 689 observational studies indexed under Pneumonia.
Browse Pneumonia studies →French Society for Intensive Care is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
patients who meet ATS/IDSA 2005 VAP criteria with microbiological confirmation
Drug: Antibiotic
patients who do not meet ATS/IDSA 2005 criteria with microbiological confirmation
Drug: Antibiotic
All antibiotic therapy characteristics are monitored.
Also known as: antimicrobial therapy
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)
Plan to share: Undecided
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French Society for Intensive Care