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

Recruiting

• Conditions: Sepsis
• Interventions: Diagnostic Test: test Aerobic/F Culture Vials; Diagnostic Test: control Aerobic/F Culture Vials

• Registration Number: NCT06426121
• Lead Sponsor: Becton, Dickinson and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-23
• Study Start: 2024-06-03
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
consistency rate	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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China