Drug Resistance Factors In Healthcare-associated Pneumonia
DEFINE
A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients
1 other identifier
observational
679
2 countries
30
Brief Summary
Recently clinical guidelines categorize pneumonia in to three types: community, healthcare-associated, and hospital-acquired. Much of the existing research to describe the epidemiology of pneumonia in critically ill patients comes from single-center studies or from retrospective database analyses, which limit generalizability and lead to over-prescription of broad-spectrum antibacterial agents. This will be a prospective, multicenter epidemiological study to characterize pneumonia epidemiology in critically ill adult patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Shorter than P25 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedAugust 1, 2017
July 1, 2017
2 months
April 8, 2016
July 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of multidrug resistant pneumonia pathogen
30 days
Secondary Outcomes (1)
Incidence of pneumonia subtypes
30 days
Eligibility Criteria
Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.
You may qualify if:
- Age ≥ 18 years old
- ICU admission
- Empiric or directed anti-infective treatment for pneumonia for ≥ 5 days
You may not qualify if:
- Patient stay in ICU for \< 24 hours
- Patient transfer to the ICU from a hospital floor following prescription for anti-infective therapy in the previous 24 hours of ICU admission
- Diagnosis of cystic fibrosis or bronchiectasis
- Fungal pneumonia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Hartford Healthcare
Hartford, Connecticut, 06102, United States
University of Florida - Jacksonville Hospital
Jacksonville, Florida, 32209, United States
Cleveland Clinic - Florida
Weston, Florida, 33331, United States
Memorial University Medical Center
Savannah, Georgia, 31401, United States
University of Chicago Medical Center
Chicago, Illinois, 60037, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Roudebush - Indianapolis Veterans Administration Hospital
Indianapolis, Indiana, 46202, United States
University of Kentucky Healthcare - Chandler Medical Center
Lexington, Kentucky, 40506, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02116, United States
Massachusetts General Hospital
Boston, Massachusetts, 02116, United States
Detroit Medical Center
Detroit, Michigan, 48201, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Beaumont Health System
Royal Oak, Michigan, 48073, United States
University of Minnesota - Fairview Health Services
Minneapolis, Minnesota, 55454, United States
Northeast Regional Medical Center
Kirksville, Missouri, 63501, United States
Lakes Regional General Healthcare
Laconia, New Hampshire, 03246, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Cleveland Clinic - Cleveland
Cleveland, Ohio, 44195, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Seton Healthcare Family
Austin, Texas, 78701, United States
Memorial Hermann Healthcare System
Houston, Texas, 77030, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, United States
Ministry of of National Guard-Health Affaires
Riyahd, 1515, Saudi Arabia
Related Publications (1)
Lat I, Daley MJ, Shewale A, Pangrazzi MH, Hammond D, Olsen KM; DEFINE study group and the Discovery Research Network. A Multicenter, Prospective, Observational Study to Determine Predictive Factors for Multidrug-Resistant Pneumonia in Critically Ill Adults: The DEFINE Study. Pharmacotherapy. 2019 Mar;39(3):253-260. doi: 10.1002/phar.2171. Epub 2018 Oct 3.
PMID: 30101412DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
April 8, 2016
First Posted
April 13, 2016
Study Start
November 1, 2016
Primary Completion
January 1, 2017
Study Completion
February 28, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share