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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

consistency rate

Time frame: 8 days

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

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 23, 2024
Registry last updated: Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed