Rapid Testing for Bacterial Blood Infections

Recruiting in Palo Alto (17 mi)

Overseen byMatthew Semler, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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 therapy, as well as a shorter duration of intensive care unit stay and hospital stay for patients who received this direct-from-blood test. We will conduct a pragmatic, randomized clinical trial examining the effect of using the T2Bacteria® Panel direct from-blood testing, compared to using blood cultures alone (standard of care), on antimicrobial receipt and clinical outcomes for adults presenting to the hospital with suspected infection and who have been initiated on empiric therapy with intravenous vancomycin.

Eligibility Criteria

Adults over 18 who are in the Emergency Department at Vanderbilt University Hospital, have been given intravenous vancomycin, and had blood cultures ordered within 12 hours of arriving. The trial is for those suspected to have a bacterial bloodstream infection.

Inclusion Criteria

You are situated in the Emergency Department of Vanderbilt University Hospital.

My doctor has prescribed IV vancomycin for me.

I arrived at the Vanderbilt ER less than 12 hours ago.

+2 more

Participant Groups

The study compares the T2Bacteria Panel, which tests directly from blood for bacteria, with usual care using blood cultures that take longer to show results. It aims to see if this rapid test can improve antibiotic use and patient outcomes.

2Treatment groups

Active Control

Group I: Usual CareActive Control1 Intervention

Patients will receive blood cultures and will not receive direct-from-blood testing.

Group II: Direct-from-blood testingActive Control1 Intervention

In addition to usual care, patients will receive direct-from-blood testing using the T2Bacteria® Panel.