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Completed

NCT Number: NCT02796716

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

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.

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Key information

Conditions

Infections Cross Infection Disease Attributes Healthcare-associated Infection Iatrogenic Disease Infection Due to Resistant Bacteria Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Subcutaneous Tissue Bacterial Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testing on new technology called Accelerate ID/AST system

Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • Accelerate Diagnostics, Inc.
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 13, 2016
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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