International Study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE)

NCT02793141 | Completed DMC

• 1 other identifier: 2015000302
• Study Type: observational
• Target: 1,657
• Locations: 2 countries
• Sites: 2

Brief Summary

The International study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE) is a prospective, international, multicentre, observational, cohort study. The study aims to provide up-to-date and generalisable information on current worldwide epidemiology and clinical practice associated with diagnosis and management of nosocomial pneumonia in Intensive Care Unit (ICU) patients. PneumoINSPIRE study is endorsed by the European Society of Intensive Care Medicine (ESICM).

Conditions

Nosocomial Pneumonia

Keywords

Pneumonia; Intensive Care Unit; Nosocomial pneumonia; Hospital-acquired pneumonia; Ventilator-associated pneumonia; ICU; HAP; VAP; Critical Care

Outcome Measures

Primary Outcomes (5)

• Mortality

  ICU and hospital mortality, censored at Day 28 if ICU discharge is later than day 28. Day 1 is the day of onset for pneumonia with arises in the ICU and day of ICU admission for pneumonia without ICU onset.

  Day 28

• Degree of concordance of clinical diagnosis of VAP with official definitions

  The degree of concordance with diagnosing nosocomial pneumonia with: 1. ATS/IDSA 2005 Guidelines 2. CDC/NHSN Surveillance definitions (Jan 2015, modified April 2015)

  Day 28 or ICU discharge, whichever occurs first

• Pathogenic organism (categorical)

  Responsible pathogens and resistance pattern by type of pneumonia and geographical region (% per category)

  Day 28 or ICU discharge, whichever occurs first

• Clinical management of pneumonia (categorical)

  Empirical management, modification of empirical management (escalation, de-escalation and discontinuation) and duration of antibiotic treatment for pneumonia

  Day 28 or ICU discharge, whichever occurs first

• Resolution of pneumonia (categorical)

  Clinical resolution of the pneumonia at pre-selected time periods

  Day 3, 7 and 14

Secondary Outcomes (3)

• Recurrence of pneumonia

  Day 14 and 28

• Mechanical ventilation-free days

  Censored at Day 28 or discharge from ICU, whichever occurs first

• Number of antibiotic-free days

  Censored at Day 28 or discharge from ICU, whichever occurs first

Study Arms (1)

ICU Nosocomial Pneumonia

Nosocomial pneumonia (hospital-acquired pneumonia) with onset in non-intubated ward patients (= or \> 48 hours after hospital admission) that due to deterioration are subsequently admitted to ICU or nosocomial pneumonia (hospital-acquired pneumonia) with onset in non-intubated ICU patients (= or \>48 hours after hospital admission) or ventilator-associated pneumonia with onset = or \> 48 hours after intubation. No intervention will be administered.

Other: No intervention

Interventions

No intervention OTHER

No intervention will be administered

ICU Nosocomial Pneumonia

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

Every ICU that will agree to participate to the study and receive ethics approval (or waiver of need for ethics approval) according to the local and national regulations in each country. Every ICU patient with the diagnosis of nosocomial pneumonia hospitalised in the ICU. Every patient with the above diagnosis, \> or = 18 years old, not receiving palliative treatment at the time of assessment for eligibility, not previously included in the study and fulfilling the inclusion criteria is eligible.

You may qualify if:

• ICU patients with a diagnosis of nosocomial pneumonia, including:
• Admission to the ICU with diagnosis of HAP that developed in the ward in non-intubated patients (Ward HAP)
• The first episode of ICU-acquired pneumonia that developed in non-intubated patients
• The first episode of ICU-acquired pneumonia that developed in patients receiving invasive ventilation (i.e. Ventilator-Associated Pneumonia (VAP)).

You may not qualify if:

• Age \< 18 years
• Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility

Sponsors & Collaborators

• The University of Queensland: lead
• European Society of Intensive Care Medicine: collaborator

Study Sites (2)

Royal Brisbane and Womens Hospital (RBWH)

Brisbane, Australia

Location

University Critical Care Department, Aghioi Anargyroi Hospital

Athens, Attica, Greece

Location

Related Publications (1)

• Koulenti D, Armaganidis A, Arvaniti K, Blot S, Brun-Buisson C, Deja M, De Waele J, Du B, Dulhunty JM, Garcia-Diaz J, Judd M, Paterson DL, Putensen C, Reina R, Rello J, Restrepo MI, Roberts JA, Sjovall F, Timsit JF, Tsiodras S, Zahar JR, Zhang Y, Lipman J; Working Group on Pneumonia of the European Society of Intensive Care Medicine. Protocol for an international, multicentre, prospective, observational study of nosocomial pneumonia in intensive care units: the PneumoINSPIRE study. Crit Care Resusc. 2023 Oct 18;23(1):59-66. doi: 10.51893/2021.1.OA5. eCollection 2021 Mar.

  PMID: 38046390 DERIVED

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• Despoina Koulenti, MD,PhD

  Post-doctoral Research Fellow, Burns Trauma and Critical Care Research Centre, Faculty of Medicine, The University of Queensland

  PRINCIPAL INVESTIGATOR

• Jeffrey Lipman, MBBCh, MD

  Director of Burns Trauma and Critical Care Research Centre, School of Medicine, The University of Queensland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: May 22, 2016
• First Posted: June 8, 2016
• Study Start: February 1, 2016
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); AU (1)