Status:
COMPLETED
Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates
Lead Sponsor:
Accelerate Diagnostics, Inc.
Conditions:
Bacteremia
Eligibility:
All Genders
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 FD...
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 Susce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 19 2022
Estimated Enrollment :
731 Patients enrolled
Trial Details
Trial ID
NCT04295915
Start Date
March 11 2020
End Date
April 19 2022
Last Update
April 22 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
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