Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02736097
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2016-04-08
Brief Title:
Drug Resistance Factors In Healthcare-associated Pneumonia
Sponsor:
Critical Care Pharmacotherapy Trials Network
Organization:
Critical Care Pharmacotherapy Trials Network
Study Overview
Official Title:
A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEFINE
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 selectionHowever 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 ie 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
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 selectionHowever 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None