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DEFINE: Drug Resistance Factors In Healthcare-associated Pneumonia

Sponsor
Critical Care Pharmacotherapy Trials Network (Other)
Overall Status
Completed
CT.gov ID
NCT02736097
Collaborator
University of Arkansas (Other)
679
Enrollment
30
Locations
3.9
Actual Duration (Months)
22.6
Patients Per Site
5.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Nov 1, 2016
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Feb 28, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of multidrug resistant pneumonia pathogen [30 days]

    Secondary Outcome Measures

    1. Incidence of pneumonia subtypes [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    2 Hartford Healthcare Hartford Connecticut United States 06102
    3 University of Florida - Jacksonville Hospital Jacksonville Florida United States 32209
    4 Cleveland Clinic - Florida Weston Florida United States 33331
    5 Memorial University Medical Center Savannah Georgia United States 31401
    6 University of Chicago Medical Center Chicago Illinois United States 60037
    7 Rush University Medical Center Chicago Illinois United States 60612
    8 Roudebush - Indianapolis Veterans Administration Hospital Indianapolis Indiana United States 46202
    9 University of Kentucky Healthcare - Chandler Medical Center Lexington Kentucky United States 40506
    10 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    11 Brigham and Women's Hospital Boston Massachusetts United States 02116
    12 Massachusetts General Hospital Boston Massachusetts United States 02116
    13 Detroit Medical Center Detroit Michigan United States 48201
    14 Spectrum Health Grand Rapids Michigan United States 49503
    15 Beaumont Health System Royal Oak Michigan United States 48073
    16 University of Minnesota - Fairview Health Services Minneapolis Minnesota United States 55454
    17 Northeast Regional Medical Center Kirksville Missouri United States 63501
    18 Lakes Regional General Healthcare Laconia New Hampshire United States 03246
    19 Hackensack University Medical Center Hackensack New Jersey United States 07601
    20 University of Rochester Medical Center Rochester New York United States 14642
    21 Mercy Medical Center Canton Ohio United States 44708
    22 Cleveland Clinic - Cleveland Cleveland Ohio United States 44195
    23 Allegheny Health Network Pittsburgh Pennsylvania United States 15212
    24 Roper St. Francis Healthcare Charleston South Carolina United States 29401
    25 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    26 Seton Healthcare Family Austin Texas United States 78701
    27 Memorial Hermann Healthcare System Houston Texas United States 77030
    28 University of Wisconsin Hospital Madison Wisconsin United States 53792
    29 Medical College of Wisconsin/ Froedtert Hospital Milwaukee Wisconsin United States
    30 Ministry of of National Guard-Health Affaires Riyahd Saudi Arabia 1515

    Sponsors and Collaborators

    • Critical Care Pharmacotherapy Trials Network
    • University of Arkansas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ishaq Lat, Primary Investigator, Critical Care Pharmacotherapy Trials Network
    ClinicalTrials.gov Identifier:
    NCT02736097
    Other Study ID Numbers:
    • 15071001
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Aug 1, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Pneumonia
    Healthcare-Associated Pneumonia
    Critical Illness

    Study Results

    No Results Posted as of Aug 1, 2017