Evaluation of the Performance of Bd Bactectm Fxi Culture System Vs Bd Bactectm Fx in the Detection of Bloodstream Infections
Investigation of Blood Culture Systems for Detecting Infections
Christopher Emery, MD
Primary Investigator
Brief description of study
This study will be conducted to demonstrate the safety and efficacy of the BACTEC FXI Culture System as compared to the BACTEC FX for blood samples. Although the protocol references pediatric sample collection, our site will only be enrolling subjects 18 years of age or older.
Detailed description of study
The primary goal of this protocol is to establish the substantial equivalence of the BACTEC FXI Culture System to the BACTEC FX across all tested media types in blood culture.
When BSI is suspected and blood cultures are ordered, an extra set for research use only (RUO) purposes will also be collected simultaneously.
There will be no further interaction with the participant. Blood collection will be conducted as part of the standard care procedures in a private room.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Blood stream infection, BSI
-
Age: 18 years or above
-
Gender: All
Inclusion criteria:
1. Is a pediatric patient or adult patient suspected of having a
BSI. (Note: Not all sites will collect specimens from
pediatric patients.)
2. Has standing or pending orders for blood culture collection
as part of routine medical care.
3. Is able to provide whole blood drawn from a venipuncture or
have a single draw from a line or other access either by
syringe and needle or by syringe and butterfly collection set.
4. For sites that require informed consent (IRB/EC dependent):
Has provided a signed and dated Informed Consent Form
(ICF) via consenting subject, or assenting subject with
consent via parent, legal guardian, or Legally Authorized
Representative (LAR).
Exclusion Criteria:
Participants are excluded from the study if any of the following
criteria apply:
1. Have any known adverse reaction to sample collection
procedures, such as uncontrolled bleeding, recurrent
fainting, or convulsions.
2. Have any medical condition that would put them at risk for
donating, as per health care professional (HCP) medical
opinion.
3. Have provided samples two prior times in this study.
4. Requires an additional venipuncture solely for study
execution.
The purpose of this study is to investigate the performance of two blood culture systems, the BACTEC FXI and the BACTEC FX, in detecting bloodstream infections. Bloodstream infections, or BSIs, occur when bacteria or fungi enter the blood, potentially causing serious illness. This study will compare the effectiveness of these systems in identifying infections from blood samples.
In this study, when a bloodstream infection is suspected, an extra set of blood samples will be collected for research purposes. This will be done at the same time as the regular blood sample collection, which is part of standard medical care. Participants will not have any additional interactions beyond this, and all procedures will be conducted in a private room.
- Who can participate: Adults aged 18 and older who have been ordered a blood culture test as part of their medical care and can provide a blood sample are eligible. They should not have adverse reactions to blood collection or have donated samples twice before in this study.
- Study details: Participants will provide an extra blood sample during their routine care when a bloodstream infection is suspected. This study does not require additional visits or interactions beyond the initial blood draw.
