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

NCT06426121 | Completed FDA Device

• 1 other identifier: IDS-23CNBAC01
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• consistency rate

  The consistency rate of the test vials and the control vials BACTEC™ system test results, including the overall consistency rate, positive consistency rate, and negative consistency rate

  8 days

Study Arms (2)

BD BACTEC™ Plus Aerobic/F Culture Vials(test)

Additional blood sample collected compared to clinical routine care

Diagnostic Test: test Aerobic/F Culture Vials

BD BACTEC™ Plus Aerobic/F Culture Vials(control)

clinical routine care

Diagnostic Test: control Aerobic/F Culture Vials

Interventions

test Aerobic/F Culture Vials DIAGNOSTIC_TEST

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

BD BACTEC™ Plus Aerobic/F Culture Vials(test)

control Aerobic/F Culture Vials DIAGNOSTIC_TEST

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

BD BACTEC™ Plus Aerobic/F Culture Vials(control)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with suspected blood infection who are at risk of sepsis

You may qualify if:

• Subject is willing to provide written informed consent to sponsor.
• Blood specimens
• Patients with suspected blood infection that have one or more of the following characteristics :
• a) Body temperature \> 38°C or body temperature \<36°C; b) chills; c) increased peripheral blood leukocyte count (count \> 10.0×109/L, especially if there is a "left shift") or decrease (count \< 3.0×109/L); d) Respiratory rate \> 20 beats/min or arterial partial pressure of carbon dioxide (PaCO2) \<32mmHg; e) Heart rate\> 90 beats/min; f) mucocutaneous hemorrhage; g) coma; h) Multi-organ dysfunction; i) decreased blood pressure; j) Elevated inflammatory response parameters such as C-reactive protein or hypersensitive C-reactive protein, procalcitonin (PCT), 1,3-β-D-glucan (G test), etc.

You may not qualify if:

• Subjects have been enrolled in this study and samples have been collected
• Patients with severe and very severe anemia (last hemoglobin \<60g/L within seven days)
• Females with known pregnancy

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: June 26, 2024
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)