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

INFECTIONS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796716
• Other study ID #: 14-1193
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: February 1, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2102
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Testing on new technology called Accelerate ID/AST system

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Accelerate Diagnostics, Inc., United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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