Advertisement

Topics

International Study on NoSocomial Pneumonia in Intensive CaRE

2016-06-08 16:23:22 | BioPortfolio

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).

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 July 2017.

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

Conditions

Nosocomial Pneumonia

Intervention

No intervention

Location

Burns Trauma and Critical Care Research Centre, School of Medicine, The University of Queensland
Brisbane
Attica
Australia

Status

Recruiting

Source

The University of Queensland

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-08T16:23:22-0400

Clinical Trials [441 Associated Clinical Trials listed on BioPortfolio]

Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia

The hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) would...

Study on ICU Patients With Nosocomial Lower Respiratory Tract Infections

This is a multicentre, multinational, prospective observational investigation on ICU critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU Hospital-acquired Pneu...

Strategies To Prevent Pneumonia 2 (SToPP2)

Ventilator-associated pneumonia is a serious complication in mechanically ventilated critically ill patients. The intervention tested in this project (swabbing the mouth with chlorhexidine...

CHIZAP: Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumonia

The aim of the study described is to measure the degree with which zinc given as adjunct therapy to standard antibiotic treatment during childhood pneumonia reduces the risk of treatment f...

Reducing Length of Stay for Veterans Hospitalized With Pneumonia

This is a pilot study to implement a computer based intervention to safely reduce length of hospital stay and time to conversion to oral antibiotics for patients with pneumonia.

PubMed Articles [4190 Associated PubMed Articles listed on BioPortfolio]

Necrotizing pneumonia caused by refractory Mycoplasma pneumonia pneumonia in children.

To investigate the clinical features of necrotizing pneumonia (NP) caused by refractory Mycoplasma pneumoniae pneumonia (RMPP).

Microbial cause of ICU-acquired pneumonia: hospital-acquired pneumonia versus ventilator-associated pneumonia.

Successful treatment of patients with hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) remains a difficult and complex undertaking. Better knowledge of the pathogens involve...

Pneumonia-Associated Hospitalizations, New York City, 2001-2014.

Death certificate data indicate that the age-adjusted death rate for pneumonia and influenza is higher in New York City than in the United States. Most pneumonia and influenza deaths are attributed to...

Efficacy of Antibiotic Prophylaxis against ventilator-associated pneumonia.

Ventilator-associated pneumonia (VAP) is one of the most important problems of intensive care units. 84 neurologic patients with acute stroke (Glasgow Coma Score ≤ 8) were entered into a double-blin...

Incidence and case fatality rates of community-acquired pneumonia and pneumococcal diseases among Korean adults: Catchment population-based analysis.

Pneumonia is a leading infectious cause of morbidity and mortality among adults. Pneumococcal pneumonia (PP) is the most common vaccine-preventable bacterial etiology of pneumonia. In this study, we e...

Medical and Biotech [MESH] Definitions

Serious INFLAMMATION of the LUNG in patients who required the use of PULMONARY VENTILATOR. It is usually caused by cross bacterial infections in hospitals (NOSOCOMIAL INFECTIONS).

Pneumonia caused by infection with bacteria of the family RICKETTSIACEAE.

Pneumonia due to aspiration or inhalation of various oily or fatty substances.

A species of the genus PNEUMOVIRUS causing pneumonia in mice.

Severe complication of pneumonia characterized by liquefaction of lung tissue.

More From BioPortfolio on "International Study on NoSocomial Pneumonia in Intensive CaRE"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Pneumonia
Pneumonia (bronchopneumonia, lobar pneumonia and double pneumonia) is inflammation (swelling) of the tissue in one or both of your lungs. It is usually caused by an pneumococcal infection caused by bacteria called Streptococcus pneumoniae.  However,...

COPD (chronic obstructive pulmonary disease)
COPD (chronic obstructive pulmonary disease) is used for a number of conditions including chronic bronchitis and emphysema, which all  lead to the airways in the lungs becoming damaged and thus narrower,  making inhalation and exhalation harder...


Searches Linking to this Trial