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Clinical Impact of a Machine Learning Decision Support System for Empirical Antibiotic Therapy
Sponsor: Instituto de Investigación Sanitaria Gregorio Marañón
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
Official title: Clinical Impact of a Machine Learning Decision Support System for Empirical Antibiotic Therapy: A Prospective Quasi-Experimental Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
486
Start Date
2026-09
Completion Date
2027-09
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
Machine Learning Decision Support System
iAST® (Pragmatech AI Solutions) is a medical device designed to assist the antibiotic prescription, currently approved by the European Medicines Agency. It used complex algorithms to accurately predict the most likely recommended antibiotics for providing coverage for specific aerobic bacteria before definitive microbiological results, bacterial identification and antibiotic susceptibility testing, were known