Using Biomarker Signature to Guide Antibiotic Treatment in Intensive Care Unit Patients to Improve Outcomes and Reduce Antibiotic Use

What this Trial Is About

Researchers are evaluating whether using a biomarker-signature BV supported antibiotic treatment decision matrix can improve antibiotic use and patient outcomes for people admitted to the Intensive Care Unit ICU. This study combines a diagnostic test with a treatment decision matrix to closely mimic real-life conditions, aiming to balance antibiotic use with patient safety. The main goal is to assess safety and effectiveness together at about 28 days, looking at antibiotic use and clinical outcomes. Participants will be randomly assigned to one of two groups. In the control group, antibiotic decisions will be made based on clinical assessment alone, with the BV test result hidden. In the intervention group, the BV test result will be shared with investigators and combined with clinical assessment using a decision matrix to guide antibiotic prescribing. The study compares these approaches to see if the biomarker-supported method reduces antibiotic exposure without causing harm. Throughout the study, participants will be monitored for outcomes such as all-cause mortality, days of antibiotic therapy, antibiotic-free days, adverse events, and ICU length of stay over about 28 days. Researchers will use a combined measure called the Desirability of Outcome Ranking Adjusted for Antibiotic Risk DOOR-RADAR to evaluate overall benefits and risks. The study will last until 2028, with assessments occurring around four weeks after treatment decisions.

Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU