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Completed

NCT Number: NCT02599220

Clinical Outcomes and Cost of Gram Negative Bacteremia

This study examines the clinical outcomes and healthcare costs associated with gram negative bacteremia at Duke University Medical Center from 2002-2015.

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Key information

Conditions

Gram-negative Bacteremia Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Up to 1 year

    The investigators are measuring in-hospital mortality

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Epidemiology, Outcomes, and Costs Associated With Gram Negative Bacteremia

Important dates

Study start
2002
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2015
Registry last updated
Nov 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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