SepsisNCT06426121
Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
An observational study of Sepsis, run by Becton, Dickinson and Company at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- What is being tested?
- test Aerobic/F Culture Vials
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2024to 23 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with suspected blood infection who are at risk of sepsis
Who may be able to join
- 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 :
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Sepsis
- Being tested
- test Aerobic/F Culture Vials, control Aerobic/F Culture Vials
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test Aerobic/F Culture VialsDiagnostic 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 VialsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| BD BACTEC™ Plus Aerobic/F Culture Vials(test) | Additional blood sample collected compared to clinical routine care Receives: Diagnostic Test: test Aerobic/F Culture Vials | |
| BD BACTEC™ Plus Aerobic/F Culture Vials(control) | clinical routine care Receives: Diagnostic Test: control Aerobic/F Culture Vials |
What is being measured
The primary outcome is the main question the study is designed to answer.
consistency rate
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
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start26 Jun 2024
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426121
- Sponsor's protocol ID
- IDS-23CNBAC01
- Status last verified
- Nov 2025
- First submitted
- 17 May 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
- ClinicalTrials.gov ID
- NCT06426121
- Acronym / sponsor ID
- IDS-23CNBAC01
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BD BACTEC™ Plus Aerobic/F Culture Vials(test) | – | Diagnostic Test: test Aerobic/F Culture VialsAdditional blood sample collected compared to clinical routine care |
| BD BACTEC™ Plus Aerobic/F Culture Vials(control) | – | Diagnostic Test: control Aerobic/F Culture Vialsclinical routine care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with suspected blood infection who are at risk of sepsis
Key inclusion criteria (4 listed)
- 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 :
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test Aerobic/F Culture Vialsan 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 | Diagnostic test | BD BACTEC™ Plus Aerobic/F Culture Vials(test) |
| control Aerobic/F Culture Vialsaccording 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 | Diagnostic test | BD BACTEC™ Plus Aerobic/F Culture Vials(control) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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Ventilator-Induced Lung Injury, Sepsis Syndrome
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Becton, Dickinson and Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consistency rate (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.