Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections

February 1, 2017 updated by: Denver Health and Hospital Authority

Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans - Task 3

This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.

To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatient or outpatient with a sample being sent for microbiology culture (respiratory, blood or tissue/skin).

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care.

Exclusion Criteria:

  • Insufficient sample volume available after sufficient aliquot removed for usual care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in empiric antimicrobial use
Time Frame: 1.5 years
Antibiotic use from the time of specimen collection until antibiotic susceptibility testing results are available to treating clinicians. Antibiotic use will be measured in days of therapy (DOT). DOT in usual care and simulated ID/AST Accelerate system will be compared
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Collaborators

United States Department of Defense
Accelerate Diagnostics, Inc.

Investigators

  • Principal Investigator: Connie S Price, MD, Denver Health
  • Principal Investigator: Ivor S Douglas, MD, Denver Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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