Clinical Trial

Clinical Impact of a Machine Learning Decision Support System for Empirical Antibiotic Therapy

Not Yet Recruiting
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Summary
The goal of this quasi-experimental study is to analyze if a Machine Learning Clinical Decision Support System can improve the empirical antibiotic treatment in patients with pneumonia, urinary tract infection and / or sepsis. The main questions it aims to answer are: * Primary outcome: clinical success defined as clinical cure (resolution of all signs and symptoms related to infection); no complications until day 30 (recurrence, or development of adverse events- AEs-); no new acquisition of MDROs; and survival at day 30. * Secondary outcomes: a subgroup analysis of the primary outcome according to the department participants, infectious syndrome, severity of the infection assessed by the SOFA score, and in microbiological confirmed infections. In microbiological confirmed infections, desirability of Outcome Ranking (DOOR) for the Management of Antimicrobial Therapy (MAT) according to the beta-lactam classification Researchers will compare a pre-intervention group with a post-intervention to see if improve in the DOOR MAT score Participants in the post-intervention group will: • Received empirical antibiotic therapy prescribed by their treating physicians according to the machine-learning recommendations
Trial Details
NCT Number NCT07762378
Lead Sponsor Instituto de Investigación Sanitaria Gregorio Marañón
Conditions Pneumonia - Bacterial, Urinary Tract Infection Bacterial, Bloodstream Infection
Enrollment 486 participants
Start Date 2026-09
Primary Completion 2027-08 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-13