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Drug Resistance Factors In Healthcare-associated Pneumonia (DEFINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02736097
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : August 1, 2017
University of Arkansas
Information provided by (Responsible Party):
Ishaq Lat, Critical Care Pharmacotherapy Trials Network

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.

Condition or disease
Pneumonia Critical Illness

Detailed Description:

Pneumonia is one of the leading causes of death in the United States and is associated with significant costs to the healthcare system. Recent treatment guidelines describe a new subtype of pneumonia, healthcare-associated pneumonia (HCAP), to identify those patients who present to a hospital from the community and are thought to be at greater risk for developing pneumonia due to multidrug resistant organisms (MDRO).

The HCAP categorization scheme is intended to improve the prescription of initial appropriate empiric antibacterial agents and minimize the morbidity and mortality associated with inappropriate empiric selection.However, one of the chief criticisms of the guideline recommendations is that the criteria used to define HCAP is overly broad, which may result in greater use of broad-spectrum antibiotics.

The prevailing notion is that many patients in the community will be at the lowest risk for experiencing MDR pneumonia and can be treated with a less broad anti-infective regimen. Patients with increasing exposure to the healthcare system will receive initial anti-infective therapy that is more broad in an effort to target MDROs. The investigator group believes that it is not simply exposure to the healthcare system that predicts the incidence of MDR pneumonia (i.e., criteria for HCAP), but rather, the "intensity" of exposure to the healthcare system that is predictive of MDR pneumonia. The aim of this study is to identify risk factors for MDR HCAP pneumonia in critically ill patients. .

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Study Type : Observational
Actual Enrollment : 679 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients
Actual Study Start Date : November 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. Incidence of multidrug resistant pneumonia pathogen [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Incidence of pneumonia subtypes [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.

Inclusion Criteria:

  • Age ≥ 18 years old
  • ICU admission
  • Empiric or directed anti-infective treatment for pneumonia for ≥ 5 days

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02736097

  Hide Study Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Connecticut
Hartford Healthcare
Hartford, Connecticut, United States, 06102
United States, Florida
University of Florida - Jacksonville Hospital
Jacksonville, Florida, United States, 32209
Cleveland Clinic - Florida
Weston, Florida, United States, 33331
United States, Georgia
Memorial University Medical Center
Savannah, Georgia, United States, 31401
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60037
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Roudebush - Indianapolis Veterans Administration Hospital
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky Healthcare - Chandler Medical Center
Lexington, Kentucky, United States, 40506
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02116
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Beaumont Health System
Royal Oak, Michigan, United States, 48073
United States, Minnesota
University of Minnesota - Fairview Health Services
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Northeast Regional Medical Center
Kirksville, Missouri, United States, 63501
United States, New Hampshire
Lakes Regional General Healthcare
Laconia, New Hampshire, United States, 03246
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Mercy Medical Center
Canton, Ohio, United States, 44708
Cleveland Clinic - Cleveland
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Roper St. Francis Healthcare
Charleston, South Carolina, United States, 29401
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Seton Healthcare Family
Austin, Texas, United States, 78701
Memorial Hermann Healthcare System
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, United States
Saudi Arabia
Ministry of of National Guard-Health Affaires
Riyahd, Saudi Arabia, 1515
Sponsors and Collaborators
Critical Care Pharmacotherapy Trials Network
University of Arkansas

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ishaq Lat, Primary Investigator, Critical Care Pharmacotherapy Trials Network Identifier: NCT02736097     History of Changes
Other Study ID Numbers: 15071001
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Healthcare-Associated Pneumonia
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Cross Infection
Iatrogenic Disease