Drug Resistance Factors In Healthcare-associated Pneumonia

NCT ID: NCT02736097

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

679 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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. .

Conditions

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Pneumonia Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role collaborator

Critical Care Pharmacotherapy Trials Network

OTHER

Sponsor Role lead

Responsible Party

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Ishaq Lat

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Hartford Healthcare

Hartford, Connecticut, United States

Site Status

University of Florida - Jacksonville Hospital

Jacksonville, Florida, United States

Site Status

Cleveland Clinic - Florida

Weston, Florida, United States

Site Status

Memorial University Medical Center

Savannah, Georgia, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Roudebush - Indianapolis Veterans Administration Hospital

Indianapolis, Indiana, United States

Site Status

University of Kentucky Healthcare - Chandler Medical Center

Lexington, Kentucky, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Detroit Medical Center

Detroit, Michigan, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Beaumont Health System

Royal Oak, Michigan, United States

Site Status

University of Minnesota - Fairview Health Services

Minneapolis, Minnesota, United States

Site Status

Northeast Regional Medical Center

Kirksville, Missouri, United States

Site Status

Lakes Regional General Healthcare

Laconia, New Hampshire, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Mercy Medical Center

Canton, Ohio, United States

Site Status

Cleveland Clinic - Cleveland

Cleveland, Ohio, United States

Site Status

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status

Roper St. Francis Healthcare

Charleston, South Carolina, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Seton Healthcare Family

Austin, Texas, United States

Site Status

Memorial Hermann Healthcare System

Houston, Texas, United States

Site Status

University of Wisconsin Hospital

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin/ Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Ministry of of National Guard-Health Affaires

Riyahd, , Saudi Arabia

Site Status

Countries

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United States Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 30101412 (View on PubMed)

Other Identifiers

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15071001

Identifier Type: -

Identifier Source: org_study_id

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