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

NCT04295915 | Completed FDA Device

• 1 other identifier: CP000026
• Study Type: observational
• Target: 731
• Locations: 1 country
• Sites: 3

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.

Conditions

Bacteremia

Keywords

Positive blood culture

Outcome Measures

Primary Outcomes (1)

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

  Approximately 4 months

Secondary Outcomes (1)

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

  Approximately 2 months

Study Arms (1)

Specimens that meet inclusion criteria

Device: Specimens that meet inclusion criteria

Interventions

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.

Specimens that meet inclusion criteria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accelerate Diagnostics, Inc.: lead

Study Sites (3)

Accelerate Diagnostics

Tucson, Arizona, 85714, United States

Location

Penn State-Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Quest/med fusion

Lewisville, Texas, 75067, United States

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

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

Study Officials

• Shelley Campeau

  Accelerate Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: March 11, 2020
• Primary Completion: December 2, 2021
• Study Completion: April 19, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)