Rapid Testing for Bacterial Blood Infections

Overseen By Ariel Lewis, MPH, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Intravenous vancomycin

Disqualifiers: Pregnancy, Prisoner, Recent positive culture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to quickly identify bacteria causing blood infections. The usual process takes up to three days, but the new test, the T2Bacteria® Panel, provides results much faster. This speed could help doctors select the right antibiotics sooner and avoid unnecessary ones, which can be harmful. The trial involves adults who received the antibiotic vancomycin in the emergency room due to suspected blood infections. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could enhance future diagnostic methods.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves patients already on intravenous vancomycin, it seems likely that you would continue with this medication if it has been prescribed.

What prior data suggests that the T2Bacteria® Panel is safe for use in diagnosing bacterial bloodstream infections?

Research has shown that the T2Bacteria® Panel is safe for people. The FDA has already approved this test to help diagnose bacterial infections in the blood. Studies have found that it can quickly and accurately detect certain bacteria without needing to grow them in a lab first. The T2Bacteria Panel is highly accurate, correctly identifying bacteria 100% of the time when present and confirming their absence 98.4% of the time.

These results suggest that the test is well-tolerated and does not pose significant risks to patients. Additionally, using this test can lead to faster treatment decisions, reducing unnecessary antibiotic use and potentially shortening hospital stays. Overall, the T2Bacteria Panel is a safe and effective tool for better managing bacterial blood infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the T2Bacteria® Panel because it offers a rapid, direct-from-blood testing method for bacterial blood infections. Unlike traditional blood cultures, which can take days to yield results, the T2Bacteria® Panel can potentially identify bacterial infections within hours. This speed can lead to quicker diagnosis and treatment, reducing the time patients spend in uncertainty and possibly improving outcomes by allowing timely interventions.

What evidence suggests that this trial's treatments could be effective for bacterial blood infections?

In this trial, participants will be divided into two groups to evaluate the effectiveness of the T2Bacteria® Panel. Research has shown that the T2Bacteria® Panel, which some participants will receive, effectively identifies bacterial infections directly from blood samples. Earlier studies demonstrated that this test correctly identified bacteria in a high percentage of cases, with a sensitivity of 84.2% and a specificity of 85.9%. It also achieved a 100% positive percent agreement, meaning that when it gives a positive result, it consistently matches other testing methods. This rapid testing method can lead to quicker, more targeted treatment, reducing the time patients spend in intensive care and in the hospital overall. Using the T2Bacteria® Panel helps avoid unnecessary use of broad-spectrum antibiotics, minimizing side effects and lowering the risk of antibiotic resistance. Meanwhile, the other group will receive usual care, which involves standard blood cultures without direct-from-blood testing. ^{3 6 7 8 9}

Who Is on the Research Team?

Matthew Semler, MD, MSc

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either usual care with blood cultures or direct-from-blood testing using the T2Bacteria® Panel

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• T2Bacteria® Panel
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Usual Care Active Control 1 Intervention

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

Group II: Direct-from-blood testing Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11124434/

Point-of-Care Method T2Bacteria®Panel Enables a More ... Results: A total of 94 patients were included. Pathogens were detected in 19 of 50 patients (38%) in the T2 group compared to 16 of 44 patients (36.4%) in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11405434/

Performance of T2Bacteria in relationship to blood cultures Overall positivity was 101 (15.8%) by either method. In 29 (28.7%) episodes, both T2Bacteria and BC were concordantly positive. In discordant ...

3. journals.asm.org journals.asm.org/doi/10.1128/jcm.00292-22

Effective Rapid Diagnosis of Bacterial and Fungal ... T2Bacteria and T2Candida panels showed 84.2% and 100% sensitivity with 85.9% and 94.1% specificity, respectively. The sensitivity and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S073646791931087X

The T2Bacteria Assay Is a Sensitive and Rapid Detector of ... Relative to BC, T2Bacteria showed 100% positive percent agreement and 98.4% negative percent agreement. In addition, for species on the T2Bacteria Panel, the ...

5. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-020-05049-9

In-depth analysis of T2Bacteria positive results in patients with ... T2Bacteria assay uses T2 magnetic resonance (T2MR) technology for the rapid diagnosis of bacterial bloodstream infections (BSIs).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11751835/

Examining the effect of direct-from-blood bacterial testing on ... The T2Bacteria panel detects five bacterial pathogens: S. aureus, Enterococcus faecium, Klebsiella pneumoniae, Pseudomonas aeruginosa and ...

7. mdpi.com mdpi.com/2076-2607/12/5/967

Point-of-Care Method T2Bacteria®Panel Enables a More ... Point-of-Care Method T2Bacteria®Panel Enables a More Sensitive and Rapid Diagnosis of Bacterial Blood Stream Infections and a Shorter Time until Targeted ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K172708.pdf

K172708 The T2Bacteria Panel is indicated as an aid in the diagnosis of bacteremia and results should be used in conjunction with other clinical and laboratory data.

9. t2biosystems.com t2biosystems.com/wp-content/uploads/2023/05/2023_MAD-ID_Poster_Bohn.pdf

The T2Bacteria Panel Covers 74% of Bacterial Pathogens ... The purpose of this study is to evaluate the proportion of organisms from bloodstream infections that were on-panel, in studies evaluating T2Bacteria.