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.

Study Overview

• Status: Completed
• Conditions: Bacteremia; Enterobacteriaceae Infections

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 89 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with bacterial blood infections.

Description

Inclusion Criteria:

• Laboratory confirmed gram negative bacilli blood culture

Exclusion Criteria:

• Pregnancy
• Prisoner

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteria identification	Accuracy of bacteria identification by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli.	3 hours
Accuracy of carbapenem susceptibility testing	Accuracy of carbapenem susceptibility testing by the Accelerate ID/AST system compared to conventional microbiological methods of gram negative bacilli.	3 hours

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Accelerate Diagnostics, Inc.
• Investigators: Principal Investigator: Connie S Price, MD, Denver Health Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Carbapenem-resistant Enterobacteriaceae; Accelerate ID/AST
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Enterobacteriaceae Infections
• Other Study ID Numbers: 15-0082; 1R01AI116993 (U.S. NIH Grant/Contract)