Drug Resistance Factors In Healthcare-associated Pneumonia

Critical Illness Clinical Trial

— DEFINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736097
• Other study ID #: 15071001
• Status: Completed
• Phase: N/A
• First received: April 8, 2016
• Last updated: July 29, 2017
• Start date: November 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: July 2017
• Source: Critical Care Pharmacotherapy Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 679
• Est. completion date: February 28, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Pneumonia

Locations

Country	Name	City	State
Saudi Arabia	Ministry of of National Guard-Health Affaires	Riyahd
United States	Seton Healthcare Family	Austin	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mercy Medical Center	Canton	Ohio
United States	Roper St. Francis Healthcare	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic - Cleveland	Cleveland	Ohio
United States	Detroit Medical Center	Detroit	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hartford Healthcare	Hartford	Connecticut
United States	Memorial Hermann Healthcare System	Houston	Texas
United States	Roudebush - Indianapolis Veterans Administration Hospital	Indianapolis	Indiana
United States	University of Florida - Jacksonville Hospital	Jacksonville	Florida
United States	Northeast Regional Medical Center	Kirksville	Missouri
United States	Lakes Regional General Healthcare	Laconia	New Hampshire
United States	University of Kentucky Healthcare - Chandler Medical Center	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	Medical College of Wisconsin/ Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Minnesota - Fairview Health Services	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	Beaumont Health System	Royal Oak	Michigan
United States	Memorial University Medical Center	Savannah	Georgia
United States	Cleveland Clinic - Florida	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Critical Care Pharmacotherapy Trials Network	University of Arkansas

Countries where clinical trial is conducted

United States,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of multidrug resistant pneumonia pathogen		30 days
Secondary	Incidence of pneumonia subtypes		30 days