Clinical Performance and Reproducibility of the Accelerat... | NCT04295915

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2020Actual

Primary Completion Date

Dec 2, 2021Actual

Completion Date

Apr 19, 2022Actual

First Submitted Date

Mar 3, 2020

First Submission Date that Met QC Criteria

Mar 3, 2020

First Posted Date

Mar 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2022

Last Update Posted Date

Apr 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

731Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Specimens that meet inclusion criteria			Device: Specimens that meet inclusion criteria

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method		Approximately 4 months

Secondary Outcomes

Measure	Description	Time Frame
Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results		Approximately 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Clinical or contrived (seeded bacterial isolate) specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Shelley Campeau	Accelerate Diagnostics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Accelerate Diagnostics		Tucson	Arizona	85714	United States
Penn State-Hershey Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms