Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture

Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02719769

Enrollment

4009

Registered

2016-03-25

Start date

2016-01-31

Completion date

2017-01-12

Last updated

2017-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Fungemia

Keywords

Positive Blood Culture

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison Study - ID Performance	Approximately 9 months (including pre-clinical phase)	Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target

Secondary

Measure	Time frame	Description
Comparison Study - AST Performance	Approximately 9 months (including pre-clinical phase)	Essential and Categorical Agreement with CLSI Frozen Reference Method (BMD) by Antimicrobial

Countries

United States

Outcome results