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

Completed

• Conditions: Enterobacteriaceae Infections; Bacteremia

• Registration Number: NCT02482051
• Lead Sponsor: Denver Health and Hospital Authority

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-25
• Study Start: 2015-07
• Primary Completion: 2022-01
• Study Completion: 2022-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Laboratory confirmed gram negative bacilli blood culture

Exclusion Criteria

• Pregnancy
• Prisoner

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacteria identification	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	3 hours	Accuracy of carbapenem susceptibility testing by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli.

Trial Locations

Locations (2)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States