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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796716
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
United States Department of Defense
Accelerate Diagnostics, Inc.
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Study Description
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Brief 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.


Condition or disease Intervention/treatment
INFECTIONS Skin and Subcutaneous Tissue Bacterial Infections Healthcare-associated Infection Infection Due to Resistant Bacteria Device: Testing on new technology called Accelerate ID/AST system

Study Design
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Study Type : Observational
Actual Enrollment : 2102 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans - Task 3
Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatient or outpatient with a sample being sent for microbiology culture (respiratory, blood or tissue/skin).
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796716


Locations
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United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
United States Department of Defense
Accelerate Diagnostics, Inc.
Investigators
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Principal Investigator: Connie S Price, MD Denver Health
Principal Investigator: Ivor S Douglas, MD Denver Health
More Information
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Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02796716    
Other Study ID Numbers: 14-1193
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Denver Health and Hospital Authority:
Wounded warriors
Battlefield infection
ESBL
MRSA
KPC
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Cross Infection
 Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Iatrogenic Disease