Comparing two types of blood culture vials for detecting sepsis
Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
Becton, Dickinson and Company · NCT06426121
This study is testing if a new type of blood culture vial can better detect blood infections in patients compared to a standard vial.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Becton, Dickinson and Company (industry) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06426121 on ClinicalTrials.gov |
What this trial studies
This observational study aims to clinically validate the effectiveness of BACTEC™ Plus Aerobic/F Culture Vials compared to an equivalent product in detecting blood infections. Participants will have blood samples collected at a single site, with samples injected into both the test and control vials for culture. The results will be monitored through the BACTEC system, and any strains grown will be identified at the species level. The study involves multiple centers to ensure a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected blood infections exhibiting symptoms such as fever, chills, or multi-organ dysfunction.
Not a fit: Patients who have severe anemia or have previously participated in this study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could improve the accuracy and speed of sepsis diagnosis, leading to better patient outcomes.
How similar studies have performed: Other studies have shown success in validating blood culture methods, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Peking University People's Hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: namei hu
- Email: namei.hu@bd.com
- Phone: +86 15800702757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis