Early Biomarker-Guided Oral Clarithromycin Treatment to Prevent Sepsis in Adults with Community-Acquired Pneumonia

What this Trial Is About

Researchers are evaluating the use of early adjunctive clarithromycin treatment guided by the biomarker suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia CAP at risk. This phase 3 randomized clinical trial aims to optimize the clinical benefit shown in a previous trial and to provide evidence that early clarithromycin can improve immune response and prevent severe outcomes in CAP patients. The study is motivated by the need for early intervention before severe sepsis develops, using suPAR levels as an early warning tool. Participants will be randomly assigned to receive either oral clarithromycin 500 mg twice daily for seven days plus standard-of-care antibiotics or a placebo tablet twice daily plus standard-of-care antibiotics. The standard antibiotics follow current guidelines and may be adjusted by the doctor based on individual factors. The study includes a quadruple-blind design to compare these two groups and will be conducted in Greece. Treatment duration for both arms is seven days. During the study, participants will have assessments at multiple time points including respiratory symptom scores, organ failure scores SOFA, and blood tests for inflammatory markers such as procalcitonin and interleukins. The main outcomes will be measured at day 4, with additional follow-up visits at 8, 14, 28, and 90 days to monitor pneumonia resolution, antibiotic use, survival, and mortality. Safety and immune response will also be tracked throughout the study to evaluate the effects of clarithromycin on CAP and sepsis progression.

Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)