An interventional study of T2Bacteria® Panel (direct-from-blood testing) and Usual Care in Bloodstream Infection, Sepsis Bacterial and MRSA Bacteremia, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Health services research
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.
1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's enrollment of 500 is above the median of 105 across 893 interventional studies indexed under Sepsis.
Browse Sepsis studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive blood cultures and will not receive direct-from-blood testing.
Other: Usual Care
In addition to usual care, patients will receive direct-from-blood testing using the T2Bacteria® Panel.
Other: T2Bacteria® Panel (direct-from-blood testing)
Providers will be prompted to order the T2Bacteria® Panel (direct-from-blood testing) and accompanying communications regarding panel results will be delivered.
Standard blood cultures.
Time to Last Dose of Intravenous Vancomycin
The time between randomization and the start time for the last dose of intravenous vancomycin received by the patient within 14 days of randomization.
Time frame: Baseline to 14 days
Time to Last Dose of Systemic Anti-pseudomonal Beta-lactam Antibiotic
The time between randomization and start time of the last dose of systemic anti-pseudomonal beta-lactam antibiotic received by the patient within 14 days of randomization.
Time frame: Baseline to 14 days
| Milestone | Usual Care | Direct-from-blood Testing |
|---|---|---|
| Started | 249 | 251 |
| Completed | 249 | 251 |
| Not completed | 0 | 0 |
The time between randomization and the start time for the last dose of intravenous vancomycin received by the patient within 14 days of randomization.
| time in hours | Usual Care | Direct-from-blood Testing |
|---|---|---|
| Time to Last Dose of Intravenous Vancomycin | 19.0 (0.90 to 64.8) | 12.5 (0.79 to 57.8) |
The time between randomization and start time of the last dose of systemic anti-pseudomonal beta-lactam antibiotic received by the patient within 14 days of randomization.
| time in days | Usual Care | Direct-from-blood Testing |
|---|---|---|
| Time to Last Dose of Systemic Anti-pseudomonal Beta-lactam Antibiotic | 1.7 (0.05 to 3.80) | 1.6 (0.04 to 3.60) |
Collected over From enrollment until end of follow-up, up to 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 9/249 (3.6%) | 0/249 (0%) | 0/249 (0%) |
| Direct-from-blood Testing | 19/251 (7.6%) | 0/251 (0%) | 0/251 (0%) |
| Age, Continuous(years) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| Median | 57 (45 to 69) | 57 (43 to 71) | 57 (44 to 70) |
| Sex: Female, Male(Participants) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| Female | 114 | 110 | 224 |
| Male | 135 | 141 | 276 |
| Race (NIH/OMB)(Participants) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 4 | 5 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 41 | 48 | 89 |
| White | 179 | 175 | 354 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 28 | 24 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 10 | 26 |
| Not Hispanic or Latino | 224 | 229 | 453 |
| Unknown or Not Reported | 9 | 12 | 21 |
| Body Mass Index(kg/m²) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| Median | 27 (22 to 31) | 26 (23 to 31) | 26.5 (22.5 to 31) |
| Sepsis(Participants) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| Count of participants | 77 | 103 | 180 |
| SOFA score ≥ 2(Participants) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| Count of participants | 47 | 31 | 78 |
| Suspected source of infection(Participants) | Usual Care | Direct-from-blood Testing | Total |
|---|---|---|---|
| Lung | 46 | 69 | 115 |
| Intra-abdominal | 39 | 24 | 63 |
| Genitourinary | 17 | 20 | 37 |
| Skin/soft tissue | 53 | 55 | 108 |
| Other | 31 | 36 | 67 |
| Unknown | 63 | 47 | 110 |
8 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
Supporting information: Study protocol, Sap, Analytic code
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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