Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates

This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Accelerate Diagnostics, Tucson, Arizona, United States

About this study

This clinical study entitled "Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens" is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017.

Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens.

The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB).

It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system
Positive blood culture sample containing gram-negative rods according to Gram stain results
For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded
A minimum sample volume of 2.0 mL
Seeded blood culture specimens derived from archived bacterial

Exclusion criteria

Blood culture positivity is > 8 hours prior to initiation of testing with the Accelerate Pheno™ system
Insufficient (less than 2.0 mL) remnant sample volume
From a patient that has already been enrolled in the study
Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media
Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity

Treatment and study plan

Specimens that meet inclusion criteria

Device

Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.

Primary outcomes

Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method

Time frame: Approximately 4 months

Secondary outcomes

Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results

Time frame: Approximately 2 months

Sponsors and collaborators

Lead sponsor

Accelerate Diagnostics, Inc.

Industry

Registry information

Official study title

Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System With New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Mar 5, 2020
Registry last updated: Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed