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Clinical Trials/NCT02685930
NCT02685930
Completed
Not Applicable

Pneumonia in the Intensive Care Unit (ICU) Setting

Washington University School of Medicine1 site in 1 country364 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
Washington University School of Medicine
Enrollment
364
Locations
1
Primary Endpoint
In-hospital mortality
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this observational study is to collect prospective data on the occurrence of bacterial and viral pneumonia in the ICU setting. Current classification systems for pneumonia promote over treatment with antibiotics as they do not specifically recognize the presence of culture-negative and viral pneumonia. The investigators will collect data to determine if a novel pneumonia classification system can be developed that more accurately links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia, antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to clinical outcomes. Additionally, the investigators will collect data on the practice of antimicrobial stewardship in the ICU setting to determine if further improvements in antibiotic practices can be accomplished in the future.

Detailed Description

The investigators will be prospectively collecting data on patients admitted to the 8300 and 8400 medical intensive care units at Barnes-Jewish Hospital requiring invasive mechanical ventilation for support in respiratory failure from pneumonia. Data will be collected on patients admitted from 1/2016-12/2016. The investigators will be collecting initial patient characteristic data as well as reviewing microbial specimen results (tracheal aspirate, bronchial alveolar lavage, viral multiplex, blood cultures) and antibiotic usage in real time. The investigators will identify any changes in antibiotic usage demonstrated with the advising of the ICU antibiotic stewardship team.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
February 1, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marin Kollef

M.D., FACP, FCCP, Professor of Medicine

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • age 18+, admitted for 8300 or 8400 medical ICU between 1/2016 and 12/2016 for respiratory failure from pneumonia, requirement of \> 24 hours of invasive mechanical ventilatory support for pneumonia

Exclusion Criteria

  • Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \> 20mg/day Prednisone equivalent, other home immunosuppressants, solid organ or bone marrow transplant patients, cystic fibrosis, bronchiectasis, active malignancy, receiving chemotherapy or radiation therapy within the past 3 months, hematologic malignancy
  • Chronic ventilator dependence

Outcomes

Primary Outcomes

In-hospital mortality

Time Frame: maxiumum of 12 months

Secondary Outcomes

  • Hospital length of stay(maximum of 12 months)
  • ICU length of stay(maximum of 12 months)
  • Total days of antibiotic, antiviral, and antifungal administration (collected both as a total days of therapy and by individual agent)(maximum of 12 months (including planned course of antibiotics to be continued upon discharge))
  • Days of invasive mechanical ventilation(maximum of 12 months)
  • 90 day readmission rate(90 days from time of discharge from index hospitalization)
  • Total days of septic shock as defined by the requirement of vasopressor therapy for maintaining a MAP > 60(maximum of 12 months)
  • Occurrence of ventilator-associated events(maximum of 12 months)
  • Disposition(maximum of 12 months)

Study Sites (1)

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