Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes

NCT06069206 | Completed Results

• 1 other identifier: 231229
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sepsis Bacterial; MRSA Bacteremia; Vancomycin; Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 14 days

Secondary Outcomes (1)

• Time to Last Dose of Systemic Anti-pseudomonal Beta-lactam Antibiotic

  Baseline to 14 days

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Direct-from-blood testing

ACTIVE COMPARATOR

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

Other: T2Bacteria® Panel (direct-from-blood testing)

Interventions

Usual Care OTHER

Standard blood cultures.

Usual Care

T2Bacteria® Panel (direct-from-blood testing) OTHER

Providers will be prompted to order the T2Bacteria® Panel (direct-from-blood testing) and accompanying communications regarding panel results will be delivered.

Direct-from-blood testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is located in the Emergency Department at Vanderbilt University Hospital
• ≤ 12 hours from patient presentation to the Emergency Department at Vanderbilt University Hospital
• Age ≥ 18 years
• Clinician has ordered blood cultures
• Clinician has ordered intravenous vancomycin

You may not qualify if:

• Patient is known to be a prisoner
• Patient is known to be pregnant
• Patient is known to have received 2 or more doses of vancomycin since presentation to the Vanderbilt ED
• Patient is known to have a positive bacterial culture in the previous 7 days
• Patient is known to have an infection for which at least 7 days of intravenous vancomycin would routinely be administered regardless of bacterial testing results (e.g., skin and soft tissue infection, etc.)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (18)

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  PMID: 33863237 BACKGROUND

• Gaston DC, Humphries RM, Lewis AA, Gatto CL, Wang L, Nelson GE, Stollings JL, Ereshefsky BJ, Christensen MA, Dear ML, Banerjee R, Miller KF, Self WH, Semler MW, Qian ET; Vanderbilt Center for Learning Healthcare. Examining the effect of direct-from-blood bacterial testing on antibiotic administration and clinical outcomes: a protocol and statistical analysis plan for a pragmatic randomised trial. BMJ Open. 2025 Jan 11;15(1):e090263. doi: 10.1136/bmjopen-2024-090263.

  PMID: 39800394 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Matthew Semler, MD, MSCI
• Organization: Vanderbilt University Medical Center

matthew.w.semler@vumc.org

615-835-9870

Study Officials

• Matthew Semler, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, Medical Director, Center for Learning Healthcare; Associate Director, Vanderbilt Medical Intensive Care Unit

Model Details: This study will be performed as a pragmatic, randomized controlled clinical trial with parallel group assignment.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: December 13, 2023
• Primary Completion: December 14, 2024
• Study Completion: April 22, 2025
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US (1)