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Protocol for an international, multicentre, prospective, observational study of nosocomial pneumonia in intensive care units: the PneumoINSPIRE study
Despoina Koulenti, Apostolos Armaganidis, Kostoula Arvaniti, Stijn Blot, Christian Brun-Buisson, Maria Deja, Jan De Waele, Bin Du, Joel M Dulhunty, Julia Garcia-Diaz, Matthew Judd, David L Paterson, Christian Putensen, Rosa Reina, Jordi Rello, Marcos I Restrepo, Jason A Roberts, Fredrik Sjovall, Jean-Francois Timsit, Sotirios Tsiodras, Jean-Ralph Zahar, Yuchi Zhang, Jeffrey Lipman, On behalf of the Working Group on Pneumonia of the European Society of Intensive Care Medicine
Crit Care Resusc 2021; 23 (1): 59-66
- Despoina Koulenti 1, 2
- Apostolos Armaganidis 2
- Kostoula Arvaniti 3
- Stijn Blot 1
- Christian Brun-Buisson 4
- Maria Deja 5
- Jan De Waele 6
- Bin Du 7
- Joel M Dulhunty 1, 8, 9
- Julia Garcia-Diaz 10, 11
- Matthew Judd 12
- David L Paterson 1, 13
- Christian Putensen 14
- Rosa Reina 15
- Jordi Rello 16, 17, 18
- Marcos I Restrepo 19, 20, 21, 22
- Jason A Roberts 1, 8, 23, 24
- Fredrik Sjovall 25
- Jean-Francois Timsit 26, 27
- Sotirios Tsiodras 28
- Jean-Ralph Zahar 29, 30
- Yuchi Zhang 31
- Jeffrey Lipman 1, 8, 32
- On behalf of the Working Group on Pneumonia of the European Society of Intensive Care Medicine 33
Jan De Waele has received a grant from the Flanders Research Foundation (Senior Clinical Investigator Grant) and has consulted for Accelerate, Bayer HealthCare, Cubist, Grifols, MSD, Pfizer (honoraria were paid to his institution). Jeffrey Lipman has given lectures with honoraria from Pfizer and MSD. David Paterson has received research grants from AstraZeneca and has attended advisory boards for, acted as a consultant to, or given lectures with honoraria from Three Rivers Pharmaceuticals, Merck, AstraZeneca, Sanofi-Aventis, Pfizer, Johnson and Johnson, Shionogi and Leo Pharmaceuticals. All other authors declare no relevant competing interests.
BACKGROUND: Nosocomial pneumonia in the critical care setting is associated with increased morbidity, significant crude mortality rates and high health care costs. Ventilator-associated pneumonia represents about 80% of nosocomial pneumonia cases in intensive care units (ICUs). Wide variance in incidence of nosocomial pneumonia and diagnostic techniques used has been reported, while successful treatment remains complex and a matter of debate.
OBJECTIVE: To describe the epidemiology, diagnostic strategies and treatment modalities for nosocomial pneumonia in contemporary ICU settings across multiple countries around the world.
DESIGN, SETTING AND PATIENTS: PneumoINSPIRE is a large, multinational, prospective cohort study of adult ICU patients diagnosed with nosocomial pneumonia. Participating ICUs from at least 20 countries will collect data on 10 or more consecutive ICU patients with nosocomial pneumonia. Site-specific information, including hospital policies on antibiotic therapy, will be recorded along with patient-specific data. Variables that will be explored include: aetiology and antimicrobial resistance patterns, treatment-related parameters (including time to initiation of antibiotic therapy, and empirical antibiotic choice, dose and escalation or de-escalation), pneumonia resolution, ICU and hospital mortality, and risk factors for unfavourable outcomes. The concordance of ventilator-associated pneumonia diagnosis with accepted definitions will also be assessed.
RESULTS AND CONCLUSIONS: PneumoINSPIRE will provide valuable information on current diagnostic and management practices relating to ICU nosocomial pneumonia, and identify research priorities in the field.
TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02793141.
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The diagnosis of VAP is difficult as clinical criteria are subjective and non-specific; also, even for microbiologically confirmed VAP, there is significant interobserver variability. 10, 11, 12, 13, 14
Successful treatment of nosocomial pneumonia is difficult and complex. 1, 2, 3, 20
Study design and coordination
- type of nosocomial pneumonia (onset before ICU admission versus onset after ICU admission; in intubated versus non-intubated patients);
- geographic region;
- patients with COPD (yes versus no);
- age of patient (< 65 years versus ≥ 65 years);
- postoperative patients (yes versus no);
- trauma patients (yes versus no); and
- full concordance with accepted diagnostic criteria (yes versus no).