Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426121
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
Clinical Validation of BACTEC Plus AerobicF Culture Vials Compared With Equivalent Product
Sponsor:
Becton Dickinson and Company
Organization:
Becton Dickinson and Company
Study Overview
Official Title:
Clinical Validation of BACTEC Plus AerobicF Culture Vials Compared With Equivalent Product
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multi-center randomized clinical validation Subjects should be fully informed of this protocol and related risks and can only be enrolled into this study after signing the informed consent form Blood collection of the subjects at the same puncture point at a single site will be injected into the test vial and the control vial respectively and the vials will be transferred to the BACTEC system for culture and the results will be observed After the BACTEC system incubation completion the vials will be subcultured Strains grown on plates will be identified using appropriate methods and if possible at the species level
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None