Assessment of Eravacycline Antimicrobial Susceptibility in China During the First Year Following Regulatory Approval...

Eravacycline, a novel fluorocycline antimicrobial, was approved by China's National Medical Products Administration (NMPA) in March 2023; however, clinical breakpoints and real-world data on its use in China remain limited. We conducted a retrospective, questionnaire-based analysis of eravacycline use across 21 provinces in China during the first year after NMPA approval (September 2023-September 2024). Data from 3369 patients who received eravacycline were collected. We analyzed the distribution of pathogens and specimens, reported in vitro susceptibility to eravacycline, imipenem, meropenem, tigecycline, and polymyxins and evaluated microbiological outcomes. Acinetobacter baumannii (52.0%, 1259/2419) and Klebsiella pneumoniae (26.1%, 631/2419) were the most commonly reported pathogens. High levels of carbapenem resistance were observed: 704 of 771 (91.3%) for A. baumannii and 323 of 392 (82.4%) for K. pneumoniae. In contrast, susceptibility to eravacycline was 95.5% (737/772) and 92.5% (297/321), respectively. Microbiological outcomes suggested potential activity against these resistant isolates, though post-treatment culture data were limited. This study demonstrates that eravacycline exhibited potent in vitro activity against prevalent carbapenem-resistant Gram-negative pathogens in real-world Chinese clinical practice during its first-year post-approval. Continuous monitoring of eravacycline resistance trends, together with prospective studies that correlate microbiological and clinical outcomes in specific infection types, will be crucial for defining its long-term therapeutic utility and the risk of resistance emergence.