Clinical trial NCT02719769: Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture
Official title: Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Fungemia
Keywords: Positive Blood Culture
Lead sponsor: Accelerate Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 4009
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.

Brief summary: The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical setting. The data from this study will be used to support the 510(k) submission for FDA clearance and global registrations of the device intended for in vitro diagnostic use.

Detailed description: The clinical study entitled "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to demonstrate the clinical performance of the Accelerate ID/AST System for positive blood culture identification (ID) and antimicrobial susceptibility testing (AST) in a clinical setting compared to reference results. Approximately 3,000 positive blood culture samples (across all Clinical Sites) will be tested on the investigational device and reference methods. Up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. Quality Control testing will be performed each day of testing. The study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. Positive blood culture samples must be tested on the Accelerate ID/AST System within 8 hours of positivity by the blood culture monitoring system. Testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.

Eligibility criteria: Inclusion Criteria:

* De-identified positive blood culture specimens (6 mL aliquot)
* Seeded blood culture specimens (stock) from archived bacterial and yeast isolates

Exclusion Criteria:

* Sample volume available \< 6 mL
* Positive Blood Culture sample \> 8 hours post-positivity
* Sample from patient previously enrolled
* Sample from blood culture media that contain charcoal e.g., BACTAlert FA, FN bottles
* Samples from Mycobacterial-type blood culture media e.g., BACTEC Myco/F Lytic, BacT/ALERT MP Bottle, VersaTREK Myco

Primary outcomes:
measure: Comparison Study - ID Performance
timeFrame: Approximately 9 months (including pre-clinical phase)
Secondary outcomes:
measure: Comparison Study - AST Performance
timeFrame: Approximately 9 months (including pre-clinical phase)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Health- Laboratory Sciences of Arizona
state: Arizona
city: Tucson
country: United States
facility: Accelerate Diagnostics Inc.
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palm Bay
country: United States
facility: MRI Global
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Liverpool
country: United States
facility: Lab Alliance of Central New York LLC
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Lewisville
country: United States
facility: med fusion LLC
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Accelerate Diagnostics, Inc.
name: Constance Bridges, B.S., MBA
role: PRINCIPAL_INVESTIGATOR
References: