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NCT06069206 · ClinicalTrials.gov registry record · NA
Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 500
- Enrollment target
NCT06069206 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 500 participants.
The verdict
NCT06069206, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
Study Summary
Bacterial blood stream infections are common and life-threatening. Bloodstream infections have historically been identified using blood cultures, which often take 24-72 hours to result and are imperfectly sensitive. Early administration of antimicrobial therapy is a fundamental component of the management of adults presenting to the hospital with a suspected bloodstream infection and/or sepsis. But because blood cultures frequently take 24-72 hours to result, patients are typically treated with empiric, broad spectrum antibiotics. In a meta-analysis of sepsis studies, empirical antibiotic therapy was inappropriate for the organism that ultimately grew in culture in almost half of patients. Thus, patients are commonly exposed to unnecessary antibiotics without evidence of infection or with evidence of infection requiring narrow antibiotic selection. For example, current guidelines recommend the use of empiric intravenous vancomycin as coverage for a bloodstream infection caused by the bacterial pathogen methicillin-resistant S. aureus (MRSA). Vancomycin requires careful monitoring due to its narrow therapeutic range and high risk of toxicity. Administration of vancomycin to patients who do not have MRSA can lead to avoidable adverse drug events and costs, as well as drive antimicrobial resistance. There has been increasing interest in using rapid diagnostic tests that identify bacteria directly from whole blood samples without relying on growth in culture, referred to as "direct-from-blood" tests, to guide early therapeutic management of patients with suspected bloodstream infections in addition to standard blood cultures. One such FDA-approved, direct-from-blood test is the T2Bacteria® Panel. This panel's performance as a direct-from blood test for bacterial pathogens has been described in previous studies. A recent meta-analysis of largely observational studies reported a faster transition to targeted microbial therapy and de-escalation of empirical microbial the
Interventions
- OTHER Usual Care
- OTHER T2Bacteria® Panel (direct-from-blood testing)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2025-04-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06069206
The ClinicalTrials.gov registry entry for NCT06069206 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT06069206 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06069206 about?
NCT06069206 is a clinical study titled "Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes". Bacterial blood stream infections are common and life-threatening. Bloodstream infections have historically been identified using blood cultures, which often take 24-72 hours to result and are imperfectly sensitive. Early administration of antimicrobial therapy is a fundamental component of the mana...
What is the current status of trial NCT06069206?
This trial is currently completed. It is a NA study. The enrollment target is 500 participants. The study started on 2023-12-13. Estimated completion is 2025-04-22.
What interventions are being tested in trial NCT06069206?
The interventions under investigation include: Usual Care (OTHER), T2Bacteria® Panel (direct-from-blood testing) (OTHER).
Who is sponsoring clinical trial NCT06069206?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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