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

NCT ID: NCT02796716

Last Updated: 2017-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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INFECTIONS Skin and Subcutaneous Tissue Bacterial Infections Healthcare-associated Infection Infection Due to Resistant Bacteria

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Testing on new technology called Accelerate ID/AST system

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Accelerate Diagnostics, Inc.

INDUSTRY

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Connie S Price, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Ivor S Douglas, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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14-1193

Identifier Type: -

Identifier Source: org_study_id

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