Viewing Study NCT02599220


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Study NCT ID: NCT02599220
Status: COMPLETED
Last Update Posted: 2015-11-06
First Post: 2015-10-28
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Clinical Outcomes and Cost of Gram Negative Bacteremia
Sponsor: Duke University
Organization:

Study Overview

Official Title: Epidemiology, Outcomes, and Costs Associated With Gram Negative Bacteremia
Status: COMPLETED
Status Verified Date: 2015-10
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: None
Brief Summary: This study examines the clinical outcomes and healthcare costs associated with gram negative bacteremia at Duke University Medical Center from 2002-2015.
Detailed Description: Specific Aim 1: Define the clinical impact of gram negative bacterial (GNB) bloodstream infections (BSI). In this objective, the investigators will describe the prevalence, source of bacteremia, and location of acquisition (i.e., community-acquired, healthcare-associated, hospital-acquired) of GNB BSI. The investigators will also examine the outcomes associated with GNB BSI including length of hospital stay, length of ICU stay, in-house mortality, and hospital costs.

Specific Aim 2: Describe antibiotic resistance patterns in GNB BSI, and explore associations between antibiotic resistance and clinical and economic outcomes. In this objective, the investigators will describe the prevalence and antibiotic susceptibility profiles of multidrug resistant phenotypes including MDR bacteria, which are defined by resistance to three or more drug classes, ESBL-producers, and CRE. The investigators will examine the differences in mortality, resource use (length of hospital stay, length of ICU stay), and direct medical costs between cases with and without antibiotic resistance.

Study Oversight

Has Oversight DMC: False
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?:

Secondary ID Infos

Secondary ID Type Domain Link View
IIR-000491 OTHER_GRANT Merck View