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

NCT02796716 | Completed

• 1 other identifier: 14-1193
• Study Type: observational
• Target: 2,102
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Wounded warriors; Battlefield infection; ESBL; MRSA; KPC

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Testing on new technology called Accelerate ID/AST system DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient or outpatient with a sample being sent for microbiology culture (respiratory, blood or tissue/skin).

You may qualify if:

• Age ≥ 18 years old
• Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care.

You may not qualify if:

• Insufficient sample volume available after sufficient aliquot removed for usual care.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• United States Department of Defense: collaborator
• Accelerate Diagnostics, Inc.: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Infections; Cross Infection

Condition Hierarchy (Ancestors)

Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Connie S Price, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

• Ivor S Douglas, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: June 13, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)