International, Multi Centre, Prospective, Observational Cohort Study of Nosocomial Pneumonia in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,657
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)).
排除标准
- •Age < 18 years
- •Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility
- •Previous inclusion in the study
结局指标
主要结局
Mortality
时间窗: 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.
Pathogenic organism (categorical)
时间窗: 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)
时间窗: 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)
时间窗: Day 3, 7 and 14
Clinical resolution of the pneumonia at pre-selected time periods
Degree of concordance of clinical diagnosis of VAP with official definitions
时间窗: 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)
次要结局
- Recurrence of pneumonia(Day 14 and 28)
- Mechanical ventilation-free days(Censored at Day 28 or discharge from ICU, whichever occurs first)
- Number of antibiotic-free days(Censored at Day 28 or discharge from ICU, whichever occurs first)
研究者
Despoina Koulenti, MD, PhD
Research Fellow
The University of Queensland