Nosocomial Pneumonia Clinical Trial
— PneumoINSPIREOfficial title:
International, Multi Centre, Prospective, Observational Cohort Study of Nosocomial Pneumonia in Intensive Care Units
Verified date | April 2021 |
Source | The University of Queensland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 1657 |
Est. completion date | February 23, 2021 |
Est. primary completion date | February 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Brisbane and Womens Hospital (RBWH) | Brisbane | |
Greece | University Critical Care Department, Aghioi Anargyroi Hospital | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
The University of Queensland | European Society of Intensive Care Medicine |
Australia, Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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) |
Day 28 or ICU discharge, whichever occurs first | |
Primary | 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 | |
Primary | 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 | |
Primary | Resolution of pneumonia (categorical) | Clinical resolution of the pneumonia at pre-selected time periods | Day 3, 7 and 14 | |
Secondary | Recurrence of pneumonia | Clinical recurrence of the pneumonia within a set period of time | Day 14 and 28 | |
Secondary | Mechanical ventilation-free days | Number of days the patient does not require mechanical ventilation whilst in ICU and censored at Day 28 | Censored at Day 28 or discharge from ICU, whichever occurs first | |
Secondary | Number of antibiotic-free days | Number of days patient did not require antibiotic therapy whilst in ICU and censored at Day 28 | Censored at Day 28 or discharge from ICU, whichever occurs first |
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