Nosocomial PneumoniaPneumoINSPIRENCT02793141
International Study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE)
An observational study of Nosocomial Pneumonia, run by The University of Queensland at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Pneumonia
- How many people
- 1,657 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2016to 23 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)).
Who cannot join
- Age < 18 years
- Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility
- Previous inclusion in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Greece1 site
University Critical Care Department, Aghioi Anargyroi Hospital
Athens, Attica
About this study
Official title: International, Multi Centre, Prospective, Observational Cohort Study of Nosocomial Pneumonia in Intensive Care Units
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).
Read the 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.
- Conditions
- Nosocomial Pneumonia
- Being tested
- No intervention
- Keywords
- Pneumonia, Intensive Care Unit, Nosocomial pneumonia, Hospital-acquired pneumonia, Ventilator-associated pneumonia, ICU, HAP, VAP, Critical Care
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be administered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Degree of concordance of clinical diagnosis of VAP with official definitions
The degree of concordance with diagnosing nosocomial pneumonia with:
- ATS/IDSA 2005 Guidelines
- CDC/NHSN Surveillance definitions (Jan 2015, modified April 2015)
Measured: 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)
Measured: 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
Measured: Day 28 or ICU discharge, whichever occurs first
Resolution of pneumonia (categorical)
Clinical resolution of the pneumonia at pre-selected time periods
Measured: Day 3, 7 and 14
Secondary outcomes (3)
Recurrence of pneumonia
Clinical recurrence of the pneumonia within a set period of time
Measured: Day 14 and 28
Mechanical ventilation-free days
Number of days the patient does not require mechanical ventilation whilst in ICU and censored at Day 28
Measured: Censored at Day 28 or discharge from ICU, whichever occurs first
Number of antibiotic-free days
Number of days patient did not require antibiotic therapy whilst in ICU and censored at Day 28
Measured: Censored at Day 28 or discharge from ICU, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start1 Feb 2016
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nosocomial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,657 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Despoina Koulenti, MD, PhD, The University of Queensland
- Investigators
- Despoina Koulenti, MD,PhD, Principal investigator, Post-doctoral Research Fellow, Burns Trauma and Critical Care Research Centre, Faculty of Medicine, The University of QueenslandJeffrey Lipman, MBBCh, MD, Study director, Director of Burns Trauma and Critical Care Research Centre, School of Medicine, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793141
- Sponsor's protocol ID
- 2015000302
- Acronym
- PneumoINSPIRE
- Status last verified
- Apr 2021
- First submitted
- 22 May 2016
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38046390
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multi Centre, Prospective, Observational Cohort Study of Nosocomial Pneumonia in Intensive Care Units
- ClinicalTrials.gov ID
- NCT02793141
- Acronym / sponsor ID
- PneumoINSPIRE / 2015000302
- Conditions
- Nosocomial Pneumonia
- Keywords
- Pneumonia, Intensive Care Unit, Nosocomial pneumonia, Hospital-acquired pneumonia, Ventilator-associated pneumonia, ICU, HAP, VAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,657 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Nosocomial Pneumonia | – | Other: No interventionNosocomial 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)).
Key exclusion criteria (3 listed)
- Age < 18 years
- Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility
- Previous inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be administered | Other | ICU Nosocomial Pneumonia |
Primary outcome
Mortality
Time frame: 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
Time frame: Day 28 or ICU discharge, whichever occurs first
The degree of concordance with diagnosing nosocomial pneumonia with: 1. ATS/IDSA 2005 Guidelines 2. CDC/NHSN Surveillance definitions (Jan 2015, modified April 2015)
Pathogenic organism (categorical)
Time frame: 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)
Time frame: 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)
Time frame: Day 3, 7 and 14
Clinical resolution of the pneumonia at pre-selected time periods
3 secondary outcomes
Recurrence of pneumonia
Time frame: Day 14 and 28
Mechanical ventilation-free days
Time frame: Censored at Day 28 or discharge from ICU, whichever occurs first
Number of antibiotic-free days
Time frame: Censored at Day 28 or discharge from ICU, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 38046390Koulenti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Despoina Koulenti, MD,PhD principal investigator
Post-doctoral Research Fellow, Burns Trauma and Critical Care Research Centre, Faculty of Medicine, The University of Queensland
Jeffrey Lipman, MBBCh, MD study director
Director of Burns Trauma and Critical Care Research Centre, School of Medicine, The University of Queensland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Pneumonia, run by The University of Queensland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.