International Study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Specifically, the study aims to:
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Evaluate the global epidemiology of nosocomial pneumonia in ICU patients, analysing responsible pathogens and resistance pattern by type of pneumonia and geographical region.
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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;
- 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:
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Evaluate nosocomial pneumonia in specific subgroups of critically ill patients (such as, chronic obstructive pulmonary disease [COPD], the elderly, postoperative, trauma patients).
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Describe the differences between nosocomial pneumonia in non-intubated ICU patients and VAP.
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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:
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Admission to the ICU with diagnosis of HAP that developed in the ward in non-intubated patients (Ward HAP)
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The first episode of ICU-acquired pneumonia that developed in non-intubated patients (ICU-HAP)
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The first episode of ICU-acquired pneumonia that developed in patients receiving invasive ventilation(i.e. Ventilator-Associated Pneumonia (VAP)).
Exclusion criteria:
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Age < 18 years
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Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility (i.e. the time of clinical diagnosis)
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
No intervention will be administered
|
Outcome Measures
Primary Outcome Measures
- Mortality [Day 28]
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.
- Degree of concordance of clinical diagnosis of VAP with official definitions [Day 28 or ICU discharge, whichever occurs first]
The degree of concordance with diagnosing nosocomial pneumonia with: ATS/IDSA 2005 Guidelines CDC/NHSN Surveillance definitions (Jan 2015, modified April 2015)
- Pathogenic organism (categorical) [Day 28 or ICU discharge, whichever occurs first]
Responsible pathogens and resistance pattern by type of pneumonia and geographical region (% per category)
- Clinical management of pneumonia (categorical) [Day 28 or ICU discharge, whichever occurs first]
Empirical management, modification of empirical management (escalation, de-escalation and discontinuation) and duration of antibiotic treatment for pneumonia
- Resolution of pneumonia (categorical) [Day 3, 7 and 14]
Clinical resolution of the pneumonia at pre-selected time periods
Secondary Outcome Measures
- Recurrence of pneumonia [Day 14 and 28]
Clinical recurrence of the pneumonia within a set period of time
- Mechanical ventilation-free days [Censored at Day 28 or discharge from ICU, whichever occurs first]
Number of days the patient does not require mechanical ventilation whilst in ICU and censored at Day 28
- Number of antibiotic-free days [Censored at Day 28 or discharge from ICU, whichever occurs first]
Number of days patient did not require antibiotic therapy whilst in ICU and censored at Day 28
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Brisbane and Womens Hospital (RBWH) | Brisbane | Australia | ||
| 2 | University Critical Care Department, Aghioi Anargyroi Hospital | Athens | Attica | Greece |
Sponsors and Collaborators
- The University of Queensland
- European Society of Intensive Care Medicine
Investigators
- Principal Investigator: Despoina Koulenti, MD,PhD, Post-doctoral Research Fellow, Burns Trauma and Critical Care Research Centre, Faculty of Medicine, The University of Queensland
- Study Director: Jeffrey Lipman, MBBCh, MD, Director of Burns Trauma and Critical Care Research Centre, School of Medicine, The University of Queensland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015000302