Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates
Public ClinicalTrials.gov record NCT04295915. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04295915
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 731 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2020 (Actual)
- Primary completion
- Dec 2, 2021 (Actual)
- Completion
- Apr 19, 2022 (Actual)
- Last update posted
- Apr 22, 2022
2020 – 2022
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Accelerate Diagnostics | Tucson | Arizona | 85714 | — |
| Penn State-Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Quest/med fusion | Lewisville | Texas | 75067 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04295915, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2022 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04295915 live on ClinicalTrials.gov.