NCT02482051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

6.5 years

First QC Date

June 23, 2015

Last Update Submit

March 28, 2022

Conditions

BacteremiaEnterobacteriaceae Infections

Keywords

Carbapenem-resistant EnterobacteriaceaeAccelerate ID/AST

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age7 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with bacterial blood infections.

You may qualify if:

  • Laboratory confirmed gram negative bacilli blood culture

You may not qualify if:

  • Pregnancy
  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

BacteremiaEnterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Negative Bacterial Infections

Study Officials

  • Connie S Price, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 25, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2022

Study Completion

January 31, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

US(2)