Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
NCT ID: NCT06426121
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
394 participants
OBSERVATIONAL
2024-06-26
2025-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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BD BACTEC™ Plus Aerobic/F Culture Vials(test)
Additional blood sample collected compared to clinical routine care
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with severe and very severe anemia (last hemoglobin \<60g/L within seven days)
* Females with known pregnancy
ALL
No
Sponsors
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Becton, Dickinson and Company
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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IDS-23CNBAC01
Identifier Type: -
Identifier Source: org_study_id
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