1200 Participants NeededMy employer runs this trial

Biomarker-Supported Antibiotics for Critical Care

(BAST-ICU Trial)

Recruiting at 3 trial locations
MS
Overseen ByMakeda Semret, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Must be taking: Antibiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific test called a BV-signature can assist doctors in making better antibiotic decisions for ICU patients. Researchers seek to discover whether this test improves antibiotic use and leads to better health outcomes. Participants will be divided into two groups: one will receive antibiotic advice based on both the test and regular clinical checks, while the other will rely solely on clinical checks. Candidates may qualify if they are in the ICU, have started antibiotics within the last three days, and their doctor is open to using test results to guide treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance antibiotic use and patient care in the ICU.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it seems that antibiotics are a focus, so you might need to discuss your antibiotic use with the trial team.

What prior data suggests that this biomarker-signature supported antibiotic treatment recommendation is safe for ICU patients?

Previous studies have generally found using biomarkers to guide antibiotic treatments safe. For example, certain biomarkers like CRP (C-reactive protein) have helped manage antibiotic use safely in seriously ill patients. One study showed that following a biomarker protocol reduced the length of antibiotic treatment by 10% without increasing death rates. This suggests that integrating biomarkers with regular medical evaluations can be safe.

Although some concerns exist about infections returning, the overall safety remains positive. Biomarkers like PCT (procalcitonin) have safely and effectively guided when to start or stop antibiotics. This reduces unnecessary antibiotic use, lowering side effects and preventing resistance.

Overall, using biomarkers to guide antibiotic treatment is well-tolerated, especially when combined with regular medical checks. This approach aids informed decisions about antibiotic use, promoting safety in critical care settings.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for biomarker-supported antibiotics in critical care because it aims to refine how antibiotics are prescribed. Unlike the standard approach, which relies solely on clinical assessment, this method combines clinical insights with a biomarker signature test to better tailor antibiotic recommendations. This innovative approach could enhance treatment precision, potentially improving patient outcomes by ensuring they receive the most effective antibiotics based on their unique biomarker profile.

What evidence suggests that this trial's treatments could be effective for ICU patients?

Research has shown that biomarkers, which are biological indicators, can help customize antibiotic treatments for ICU patients. One study found that a specific combination of these indicators effectively distinguished between bacterial and viral infections, aiding doctors in selecting the right antibiotic. In this trial, one group of participants will receive antibiotic treatment recommendations based solely on clinical assessment, while another group will combine clinical assessment with biomarker-supported recommendations. Other studies suggest that using biomarkers to guide treatment can improve patient outcomes by reducing unnecessary antibiotic use, potentially leading to faster recovery with fewer side effects. Overall, biomarkers offer a promising way to make smarter and more effective treatment decisions in the ICU.12367

Are You a Good Fit for This Trial?

This trial is for ICU patients who started antibiotics within the last 3 days for a suspected or confirmed infection, and whose doctors are open to using a special blood test (BV) to help guide antibiotic decisions. People with advanced cancer, severe immune problems, or those near end of life cannot join.

Inclusion Criteria

Started on antibiotics for any suspected or confirmed infection in the preceding 72 hours (about 3 days)
Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making
I have been admitted to the ICU.

Exclusion Criteria

I have advanced cancer that has spread to other parts of my body.
I will stop taking antibiotics within 24 hours.
Palliative intent, death imminent and inevitable within 4 weeks
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive antibiotic treatment based on either clinical assessment alone or combined with BV-signature test results

4 weeks
Regular monitoring visits as per ICU protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and clinical outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Biomarker-signature supported antibiotic treatment recommendation

Trial Overview

The study compares usual doctor-led decisions about antibiotics versus using results from a biomarker blood test (BV signature) to help decide when and how to use antibiotics in ICU patients. Participants are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Combined clinical and BV-supported antibiotic treatment recommendationExperimental Treatment2 Interventions
Group II: Clinically-Supported Antibiotic Treatment RecommendationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Citations

Use of biomarkers to individualize antimicrobial therapy ...

In this review, we discuss evidence from the studies that have assessed how biomarkers may inform an individualized approach to the duration of AMT.

A new biomarker combination differentiates viral from bacterial ...

The test showed good performance in differentiating bacterial from viral infections in multiple prospective validation studies and in different ...

NCT07481773 | Biomarker Signature-Supported Antibiotic ...

The goal of this randomized clinical trial is to determine whether a biomarker-signature (BV) supported antibiotic treatment decision matrix can have a ...

Predictive enrichment using biomarkers in studies of critically ...

This review characterizes the use of biomarkers for predictive enrichment in randomized trials of critically-ill patients with sepsis. Although ...

Biomarker Signature-Supported Antibiotic Treatment ...

The goal of this randomized clinical trial is to determine whether a biomarker-signature (BV) supported antibiotic treatment decision matrix ...

What's the best strategy for biomarker-guided antibiotic ...

Although a few studies raised concerns about infection recurrence, the overall safety profile remains favorable. CRP-guided strategies, while ...

Analysis of ICU resistome dynamics in patients, staff and ...

Strikingly, up to half of ICU patients receive empirical antibiotic therapy without a definitively confirmed infection. Selection pressure and ...