Clinical trial NCT02599220: Clinical Outcomes and Cost of Gram Negative Bacteremia
Official title: Epidemiology, Outcomes, and Costs Associated With Gram Negative Bacteremia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-negative Bacteremia
Bacteremia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-11-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Duke Bloodstream Infection Biorepository (BSIB) contains prospectively collected clinical data on \~2000 unique inpatients at Duke with monomicrobial gram negative bacteria bloodstream infections.

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.

Eligibility criteria: Inclusion Criteria:

Since January 2002, one investigator (VGF) has received daily reports from the clinical microbiology laboratory on all hospitalized patients at Duke University Medical Center with one or more blood culture(s) positive for gram negative rods. Patients were then evaluated within 36 hours of the detection of bacteremia for clinical evidence of infection

Exclusion Criteria:

Patients were excluded from the study for the following reasons: age less than 18 years, polymicrobial infection (blood culture positive for more than one pathogen), neutropenia (white blood cell count less than 1.0 x 109/L), or death prior to the return of positive blood cultures. In order to preserve the independence of observations, only the initial episode of gram negative bacteremia was included in the analysis (e.g., patients were only included once). The study was approved by the Duke University Medical Center Institutional Review Board.

Primary outcomes:
measure: Mortality
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Vance G Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References: