Clinical trial NCT02736097: Drug Resistance Factors In Healthcare-associated Pneumonia
Official title: A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Critical Illness
Lead sponsor: Critical Care Pharmacotherapy Trials Network
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2016-04-13
Enrollment: 679
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.

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.

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. .

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of multidrug resistant pneumonia pathogen
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of pneumonia subtypes
timeFrame: 30 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic - Florida
state: Florida
city: Savannah
country: United States
facility: Memorial University Medical Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Roudebush - Indianapolis Veterans Administration Hospital
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Healthcare - Chandler Medical Center
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota - Fairview Health Services
state: Minnesota
city: Kirksville
country: United States
facility: Northeast Regional Medical Center
state: Missouri
city: Laconia
country: United States
facility: Lakes Regional General Healthcare
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Canton
country: United States
facility: Mercy Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Cleveland
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Seton Healthcare Family
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Healthcare System
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/ Froedtert Hospital
state: Wisconsin
city: Riyahd
country: Saudi Arabia
facility: Ministry of of National Guard-Health Affaires
Study officials:
References:
citation: 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.