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

NCT02796716 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2102

Last updated 2017-02-02

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Testing on new technology called Accelerate ID/AST system

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • Accelerate Diagnostics, Inc.

    collaborator INDUSTRY
  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Connie S Price, MD · Denver Health

  • Ivor S Douglas, MD · Denver Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796716 on ClinicalTrials.gov