## Protocol Section
### Identification Module
**NCT ID:** NCT06426121

**Brief Title:** Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product

**Official Title:** Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product

#### Organization Study ID Info
**ID:** IDS-23CNBAC01
#### Organization
**Class:** INDUSTRY
**Full Name:** Becton, Dickinson and Company
### Status Module
#### Completion Date
**Date:** 2025-03-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-03-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Becton, Dickinson and Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Blood Culture of Microorganisms

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Additional blood sample collected compared to clinical routine care

**Intervention Names:**

- Diagnostic Test: test Aerobic/F Culture Vials

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

#### Arm Group 2

**Description:** clinical routine care

**Intervention Names:**

- Diagnostic Test: control Aerobic/F Culture Vials

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

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

**Description:** 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

**Name:** test Aerobic/F Culture Vials

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

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

**Description:** 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

**Name:** control Aerobic/F Culture Vials

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** consistency rate

**Time Frame:** 8 days

### Eligibility Module

**Eligibility Criteria:** 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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** patients with suspected blood infection who are at risk of sepsis

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** namei.hu@bd.com

**Name:** namei hu

**Phone:** +86 15800702757

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
