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

Launched by BECTON, DICKINSON AND COMPANY · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new blood culture method called BACTEC™ Plus Aerobic/F to see how well it can detect infections in patients suspected of having sepsis, a serious condition caused by infections. Participants will donate blood samples, which will be placed in two different vials: the new one and a standard one. Both vials will be analyzed to see which one can identify the infection more effectively.

To join this study, participants must be willing to provide written consent and have symptoms suggesting a possible blood infection, such as a high or low fever, chills, or rapid heart rate. However, individuals who are currently enrolled in the study, have severe anemia, or are pregnant will not be eligible. Those who participate can expect to have their blood drawn once, and their samples will be carefully examined to help improve how infections are diagnosed in the future.

Gender

ALL

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