San Vicente

Researchers are evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in adults hospitalized with severe community-acquired pneumonia (sCAP) who require invasive mechanical ventilation. This phase III, randomized, placebo-controlled, double-blind, multi-center trial aims to compare trimodulin plus standard care against placebo plus standard care. The study also includes substudies to understand the pharmacokinetics and pharmacodynamics of trimodulin. Participants will be randomly assigned to receive either trimodulin or placebo via intravenous infusion once daily for five consecutive days alongside standard care. After the treatment phase, patients will be followed for up to 23 days, with an end-of-follow-up visit or telephone call on day 29. For those still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a final visit or call on day 91. During the study, participants will undergo various assessments including monitoring of mortality rates up to day 29, clinical evaluations, and safety monitoring. Researchers will collect data on inflammation markers and other health parameters. Follow-up contacts and visits will ensure ongoing evaluation of patient status and adverse events throughout the study period, which may last up to 91 days or longer depending on hospital discharge timing.