Objective: To evaluate the clinical efficacy and safety of biapenem (Bianem-AF) for treating severe infections in ICU settings.

Materials and Methods: A prospective observational study was conducted. Phase 1 involved microbiological testing of 51 isolates from ICU patients to determine susceptibility to meropenem and biapenem (MIC) and identify carbapenemase genes. Phase 2 included 19 adult patients with sepsis requiring surgical intervention. Treatment consisted of biapenem 600mg (initial bolus, followed by 1-hour prolonged infusions every 12 hours). Daily monitoring assessed inflammatory response, organ dysfunction, and safety profiles.

Results: Klebsiella pneumoniae represented 52.9% of isolates; 48% were resistant to both carbapenems due to serine and metallo-carbapenemase genes. Resistance in other Enterobacteriales was 12.5%. Clinical response to biapenem was achieved in 100% of patients. Procalcitonin levels significantly decreased from 4.65 ng/mL to 0.6 ng/mL by day 7. Median SOFA scores improved from 3.0 to 2.0 within 24 hours. Critically, no adverse events were registered during biapenem administration. Specifically, no cardiovascular adverse events occurred, including in severe cardiology patients following cardiac surgery.

Conclusion: Considering the high prevalence of ESBL-producing strains and Pseudomonas, biapenem demonstrates high efficacy. Its favorable safety profile, specifically the absence of cardiovascular complications even in high-risk post-cardiac surgery patients, justifies its use for empirical therapy of sepsis caused by multidrug-resistant Gram-negative organisms.

Dr. Valeria Panafidina is a distinguished intensivist and academic leader in the field of critical care medicine. Demonstrating exceptional promise early in her career, she successfully defended her PhD at the remarkable age of 28.Currently, Dr. Panafidina holds a dual role that bridges clinical practice and medical education. She serves as a faculty member at Pavlov First Saint Petersburg State Medical University, where she mentors the next generation of physicians. Simultaneously, she works actively in an ICU, applying her expertise to treat critically ill patients.A pioneer in Russian critical care research, Dr. Panafidina is the founder of the country's first multicenter database dedicated to patients with sepsis. This groundbreaking initiative has significantly advanced the understanding of sepsis epidemiology and treatment outcomes within Russia, facilitating large-scale data analysis and improving clinical standards. Her work continues to influence both academic discourse and practical healthcare delivery in the region.