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Drug Resistance Factors In Healthcare-associated Pneumonia (DEFINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02736097
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : August 1, 2017
University of Arkansas
Information provided by (Responsible Party):
Ishaq Lat, Critical Care Pharmacotherapy Trials Network

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
Pneumonia Critical Illness

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. .

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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 : November 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. Incidence of multidrug resistant pneumonia pathogen [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Incidence of pneumonia subtypes [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02736097

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Sponsors and Collaborators
Critical Care Pharmacotherapy Trials Network
University of Arkansas

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ishaq Lat, Primary Investigator, Critical Care Pharmacotherapy Trials Network Identifier: NCT02736097     History of Changes
Other Study ID Numbers: 15071001
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Healthcare-Associated Pneumonia
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Cross Infection
Iatrogenic Disease