Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates
Completed
Conditions studied: Bacteremia
In brief
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.
Key facts
- Study ID
- NCT04295915
- Run by
- Accelerate Diagnostics, Inc.
- People needed
- 731
- Starts
- 2020-03-11
- Expected to finish
- 2022-04-19
- Last updated by the study team
- 2022-04-22
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Accelerate Diagnostics — Tucson, Arizona, United States
- Penn State-Hershey Medical Center — Hershey, Pennsylvania, United States
- Quest/med fusion — Lewisville, Texas, United States
Full record on ClinicalTrials.gov
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