Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood

The purpose of this study is to develop a new and very rapid diagnostic test for identifying a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of bacteria will assist in decreasing the use of antibiotics and help more patients survive bacterial infections of the blood.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

7 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital, Aurora, Colorado, United States

About this study

It is our overall goal to develop a new diagnostic technology that will facilitate antibacterial stewardship to reduce selective pressure and improve patient outcomes. The Institute of Medicine has identified antibiotic resistance as one of the key microbial threats to health in the United States and has prioritized decreasing inappropriate use of antimicrobials as the primary solution to address this threat. The emergence of carbapenem resistance among Enterobacteriaceae (CRE) in the United States represents a recent and severe byproduct of excessive antimicrobial use with a high mortality rate in bacteremia. A major barrier toward decreasing use of antimicrobials is lack of sensitive and accurate rapid diagnostic tests for identifying bacterial etiologies of infection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Laboratory confirmed gram negative bacilli blood culture

Exclusion criteria

Pregnancy
Prisoner

Treatment and study plan

Primary outcomes

Bacteria identification

Time frame: 3 hours

Accuracy of bacteria identification by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli.
Accuracy of carbapenem susceptibility testing

Time frame: 3 hours

Accuracy of carbapenem susceptibility testing by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli.

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

Accelerate Diagnostics, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Jun 25, 2015
Registry last updated: Mar 29, 2022

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.

Published trials that share one or more normalized conditions with this study.

Recruiting