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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: test Aerobic/F Culture Vials; Diagnostic test: control Aerobic/F Culture Vials

• Study Type: Observational
• Enrollment (Actual): 394

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with suspected blood infection who are at risk of sepsis

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BD BACTEC™ Plus Aerobic/F Culture Vials(test); Additional blood sample collected compared to clinical routine care	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
BD BACTEC™ Plus Aerobic/F Culture Vials(control); clinical routine care	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Actual): October 23, 2025
• Study Completion (Actual): October 23, 2025

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: IDS-23CNBAC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes