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

Becton, Dickinson and Company (BD)

Status: Enrolling

Conditions: Sepsis

Treatments: Diagnostic Test: control Aerobic/F Culture Vials; Diagnostic Test: test Aerobic/F Culture Vials

Study type: Observational

Funder types: Industry

Identifiers

NCT06426121

IDS-23CNBAC01

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

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

Description:

Additional blood sample collected compared to clinical routine care

Treatment:

Diagnostic Test: test Aerobic/F Culture Vials

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

Description:

clinical routine care

Treatment:

Diagnostic Test: control Aerobic/F Culture Vials