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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02793141




Registration number
NCT02793141
Ethics application status
Date submitted
22/05/2016
Date registered
8/06/2016
Date last updated
3/05/2021

Titles & IDs
Public title
International Study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE)
Scientific title
International, Multi Centre, Prospective, Observational Cohort Study of Nosocomial Pneumonia in Intensive Care Units
Secondary ID [1] 0 0
2015000302
Universal Trial Number (UTN)
Trial acronym
PneumoINSPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nosocomial Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

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 interventions: No intervention
No intervention will be administered
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
Day 28
Primary outcome [2] 0 0
Degree of concordance of clinical diagnosis of VAP with official definitions
Timepoint [2] 0 0
Day 28 or ICU discharge, whichever occurs first
Primary outcome [3] 0 0
Pathogenic organism (categorical)
Timepoint [3] 0 0
Day 28 or ICU discharge, whichever occurs first
Primary outcome [4] 0 0
Clinical management of pneumonia (categorical)
Timepoint [4] 0 0
Day 28 or ICU discharge, whichever occurs first
Primary outcome [5] 0 0
Resolution of pneumonia (categorical)
Timepoint [5] 0 0
Day 3, 7 and 14
Secondary outcome [1] 0 0
Recurrence of pneumonia
Timepoint [1] 0 0
Day 14 and 28
Secondary outcome [2] 0 0
Mechanical ventilation-free days
Timepoint [2] 0 0
Censored at Day 28 or discharge from ICU, whichever occurs first
Secondary outcome [3] 0 0
Number of antibiotic-free days
Timepoint [3] 0 0
Censored at Day 28 or discharge from ICU, whichever occurs first

Eligibility
Key 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)).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age < 18 years

- Patients with nosocomial pneumonia receiving palliative treatment at the time of
assessment for eligibility

- Previous inclusion in the study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/02/2021
Sample size
Target
Accrual to date
Final
1657
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane and Womens Hospital (RBWH) - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Attica

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Society of Intensive Care Medicine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02793141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Despoina Koulenti, MD,PhD
Address 0 0
Post-doctoral Research Fellow, Burns Trauma and Critical Care Research Centre, Faculty of Medicine, The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02793141