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

Sponsor

Accelerate Diagnostics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04295915

Collaborator

(none)

731

Enrollment

Locations

25.3

Actual Duration (Months)

243.7

Patients Per Site

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bacteremia	Device: Specimens that meet inclusion criteria

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

731 participants

Observational Model:

Other

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Mar 11, 2020

Actual Primary Completion Date :

Dec 2, 2021

Actual Study Completion Date :

Apr 19, 2022

Arms and Interventions

Arm	Intervention/Treatment
Specimens that meet inclusion criteria	Device: Specimens that meet inclusion criteria 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.

Arm

Intervention/Treatment

Specimens that meet inclusion criteria

Device: Specimens that meet inclusion criteria

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.

Outcome Measures

Primary Outcome Measures

Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method [Approximately 4 months]

Secondary Outcome Measures

Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results [Approximately 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accelerate Diagnostics	Tucson	Arizona	United States	85714
2	Penn State-Hershey Medical Center	Hershey	Pennsylvania	United States	17033
3	Quest/med fusion	Lewisville	Texas	United States	75067

Sponsors and Collaborators

Accelerate Diagnostics, Inc.

Investigators

Study Director: Shelley Campeau, Accelerate Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Accelerate Diagnostics, Inc.

ClinicalTrials.gov Identifier:

NCT04295915

Other Study ID Numbers:

CP000026

First Posted:

Mar 5, 2020

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Accelerate Diagnostics, Inc.

Positive blood culture

Additional relevant MeSH terms:

Bacteremia

Study Results

No Results Posted as of Apr 22, 2022