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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796716
Other study ID # 14-1193
Secondary ID
Status Completed
Phase N/A
First received May 11, 2016
Last updated February 1, 2017
Start date July 2015
Est. completion date December 2016

Study information

Verified date February 2017
Source Denver Health and Hospital Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 2102
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Testing on new technology called Accelerate ID/AST system


Locations

Country Name City State
United States Denver Health Medical Center Denver Colorado

Sponsors (3)

Lead Sponsor Collaborator
Denver Health and Hospital Authority Accelerate Diagnostics, Inc., United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in empiric antimicrobial use 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
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