NCT06426121

Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 394 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	test Aerobic/F Culture Vials	an additional blood sample will be collected compared to clinical routine of blood culture, inoculated into the test culture vial, and compared with the blood culture results of the control vial collected from the same site and the same puncture point
DIAGNOSTIC_TEST	control Aerobic/F Culture Vials	according to the clinical routine of blood culture, this blood sample should be collected and inoculated into the control vial, and its culture result will be collected

Timeline

• Start date: 2024-06-26
• Primary completion: 2025-10-23
• Completion: 2025-10-23
• First posted: 2024-05-23
• Last updated: 2025-11-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study