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

NCT06426121 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 394

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2025-10-23
Completion
2025-10-23
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06426121 on ClinicalTrials.gov