Drug Resistance Factors In Healthcare-associated Pneumonia (DEFINE)

July 29, 2017 updated by: Ishaq Lat, Critical Care Pharmacotherapy Trials Network

A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients

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.

Study Overview

Status

Completed

Conditions

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. .

Study Type

Observational

Enrollment (Actual)

679

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of multidrug resistant pneumonia pathogen
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of pneumonia subtypes
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Critical Care Pharmacotherapy Trials Network

Collaborators

University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 29, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15071001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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