Clinical trial NCT02793141: International Study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE)
Official title: International, Multi Centre, Prospective, Observational Cohort Study of Nosocomial Pneumonia in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Pneumonia
Keywords: Pneumonia
Intensive Care Unit
Nosocomial pneumonia
Hospital-acquired pneumonia
Ventilator-associated pneumonia
ICU
HAP
VAP
Critical Care
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2016-06-08
Enrollment: 1657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Detailed description: Specifically, the study aims to:

* Evaluate the global epidemiology of nosocomial pneumonia in ICU patients, analysing responsible pathogens and resistance pattern by type of pneumonia and geographical region.
* Describe on a global scale current clinical practice regarding diagnosis and determine the degree of concordance between the diagnosis of nosocomial pneumonia in routine clinical practice and the official definitions including: a) ATS/IDSA 2005 guidelines; b) CDC/NHSN Surveillance Definitions (version January 2015, modified April 2015).
* Identify on a global scale variable treatment decisions with emphasis on therapeutic schemas, appropriateness, de-escalation decisions and their relation to outcomes.

Secondary objectives include:

* Evaluate nosocomial pneumonia in specific subgroups of critically ill patients (such as, chronic obstructive pulmonary disease \[COPD\], the elderly, postoperative, trauma patients).
* Describe the differences between nosocomial pneumonia in non-intubated ICU patients and VAP.
* Compare the characteristics and outcomes between patients with nosocomial pneumonia in ward patients later transferred to the ICU and non-intubated ICU patients with nosocomial pneumonia.

This international study will explore clinical details for nosocomial pneumonia in the ICU setting: practice variations among countries and continents, diagnostic and treatment modalities, implicated pathogens and their resistance patterns, resolution patterns and risk factors for unfavourable outcomes. In view of these, this global multicentre study shall provide useful information for the elaboration of future recommendations on diagnostic and treatment approaches for nosocomial pneumonia in the ICU.

Inclusion criteria:

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 (ICU-HAP)
* The first episode of ICU-acquired pneumonia that developed in patients receiving invasive ventilation(i.e. Ventilator-Associated Pneumonia (VAP)).

Exclusion criteria:

* Age \< 18 years
* Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility (i.e. the time of clinical diagnosis)
* Previous inclusion in the study

Research sites:

More than 150 ICUs from 25 or more countries worldwide that will agree to participate in the study.

Sample size:

A minimum of 10 consecutive ICU patients with nosocomial pneumonia as described above will be recruited per site. A sample size of at least 1000 ICU patients with nosocomial pneumonia is anticipated to comprise the dataset. This sample size has been chosen to provide generalisable data for each geographic region and to satisfy power considerations.

Statistical analysis:

Descriptive analytic, techniques and parametric and non-parametric tests will be used to explore diagnostic, microbiological or subgroup differences as well as clinical outcomes of nosocomial pneumonia. Cox regression will be used to predict dichotomous outcomes of interest, including mortality and pneumonia resolution. Independent predictors and associated hazard ratios with 95% confidence intervals will be reported. A two-sided p-value less than 0.05 will be considered statistically significant.

Proposed Start and End Date:

The first site is anticipated to commence recruitment in March 2016 with staggered site recruitment; however, sites are anticipated to start recruitment during the first half of 2016; each site will commence recruitment as soon as relevant Institutional Review Board approvals have been obtained. Recruitment will continue until the minimum target of 10 patients has been reached. Sites will have the opportunity for further recruitment while the study is active. Completion of recruitment is anticipated to occur by end December 2018.

Dissemination of Findings:

Summary data will be presented in a timely manner at national and international conferences and in peer-reviewed journals.

Eligibility criteria: Inclusion Criteria:

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)).

Exclusion Criteria:

* Age \< 18 years
* Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility
* Previous inclusion in the study

Primary outcomes:
measure: Mortality
timeFrame: Day 28
measure: Degree of concordance of clinical diagnosis of VAP with official definitions
timeFrame: Day 28 or ICU discharge, whichever occurs first
measure: Pathogenic organism (categorical)
timeFrame: Day 28 or ICU discharge, whichever occurs first
measure: Clinical management of pneumonia (categorical)
timeFrame: Day 28 or ICU discharge, whichever occurs first
measure: Resolution of pneumonia (categorical)
timeFrame: Day 3, 7 and 14
Secondary outcomes:
measure: Recurrence of pneumonia
timeFrame: Day 14 and 28
measure: Mechanical ventilation-free days
timeFrame: Censored at Day 28 or discharge from ICU, whichever occurs first
measure: Number of antibiotic-free days
timeFrame: Censored at Day 28 or discharge from ICU, whichever occurs first
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane and Womens Hospital (RBWH)
city: Athens
country: Greece
facility: University Critical Care Department, Aghioi Anargyroi Hospital
state: Attica
Study officials:
affiliation: Post-doctoral Research Fellow, Burns Trauma and Critical Care Research Centre, Faculty of Medicine, The University of Queensland
name: Despoina Koulenti, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Burns Trauma and Critical Care Research Centre, School of Medicine, The University of Queensland
name: Jeffrey Lipman, MBBCh, MD
role: STUDY_DIRECTOR
References: