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

Completed

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

• Registration Number: NCT02796716
• Lead Sponsor: Denver Health and Hospital Authority

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2102

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in empiric antimicrobial use	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

Trial Locations

Locations (1)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States