P-1475. Real-World Effectiveness and Safety of Cefiderocol in the Treatment of Patients with Serious Gram-negative Bacterial Infections: Results of the PROVE Chart Review Study

Abstract Background The ongoing PROVE retrospective chart review study aims to assess real-world outcomes of cefiderocol treatment in patients with serious Gram-negative bacterial infections. Methods This is an interim analysis of hospitalized patients with suspected or confirmed Gram-negative bacterial infections in Europe and the USA treated with cefiderocol for the first time for ≥72 hours (Nov 2020–Feb 2024). A total of 1000 patients are planned. Baseline demographics, clinical characteristics, cefiderocol use, clinical cure, clinical response at end of treatment (EOT), in-hospital all-cause mortality (ACM), and adverse drug reactions (ADRs) were assessed. Results Of 774 patients analyzed, 498 (64.3%) were men and the median age (interquartile range [IQR]) was 59 (45–69) years (Table 1); 90.1% of patients had ≥1 risk factor for carbapenem-resistant infections. Overall, 59.8% were in the intensive care unit (ICU) and 48.1% received organ support. Cefiderocol was used as first-line therapy in 70.3% of patients; the median (IQR) duration was 11 (8–16) days. The most frequent infection site was the respiratory tract (RTI; 54.1%), and the most frequent species in monomicrobial infections was Pseudomonas aeruginosa (35.3%), followed by Acinetobacter baumannii (19.6%) (Figure 1). Overall, 64.0% of patients had clinical cure and 71.6% responded to cefiderocol treatment at EOT. ACM rates at days 14 and 30 were 15.6% and 24.3%, respectively (Table 2). Clinical cure and clinical response rates were 58.0% and 68.0% in patients with RTI, and 66.7% and 74.1% in patients with bloodstream infection (BSI), respectively. Among patients with RTI or BSI, 31.0% and 18.5% died by day 30, respectively. Among patients with P. aeruginosa infection, 67.0% and 75.8% had clinical cure and clinical response, and 22.3% died by day 30. In monomicrobial and polymicrobial infections, clinical cure rates were 63.6% and 65.0%, while ACM rates were 25.6% and 20.0% at day 30, respectively (Table 2). A total of 19 patients had 23 ADRs or serious ADRs, which led to discontinuation of cefiderocol for 11 events (Table 3). Conclusion Cefiderocol was efficacious and well tolerated for the treatment of serious Gram-negative bacterial infections in real-world settings in a patient population with high rates of ICU admission and organ support. Disclosures Cornelius J. Clancy, MD, Cidara: Grant/Research Support|Gilead: Honoraria|Merck: Grant/Research Support|Scynexis: Advisor/Consultant|Shionogi: Advisor/Consultant|Venatorx: Advisor/Consultant Oliver A. Cornely, Prof. Dr., Abbott: Honoraria|Abbvie: Advisor/Consultant|Abbvie: Honoraria|AiCuris: Advisor/Consultant|Akademie fur Infektionmedizin: Honoraria|Al-Jazeera Pharmaceuticals/Hikma: Honoraria|amedes: Honoraria|AstraZeneca: Honoraria|Basilea: Advisor/Consultant|Biocon: Advisor/Consultant|BMBF: Grant/Research Support|Boston Strategic Partners: Advisor/Consultant|CIdara: Advisor/Consultant|CIdara: Expert Testimony|CIdara: Grant/Research Support|CIdara: Participation on a DRC or DSMB|CoRe Consulting: Stocks/Bonds (Private Company)|Deutscher Arzteverlag: Honoraria|DZIF: Grant/Research Support|EasyRadiology: Stocks/Bonds (Private Company)|EU-DG RTD: Grant/Research Support|F2G: Grant/Research Support|Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Honoraria|Grupo Biotoscana/United Medical/Knight: Honoraria|GSK: Advisor/Consultant|GSK: Honoraria|IQVIA: Advisor/Consultant|IQVIA: Participation on a DRC or DSMB|Janssen: Advisor/Consultant|Janssen: Participation on a DRC or DSMB|Matinas: Advisor/Consultant|MedPace: Advisor/Consultant|MedPace: Grant/Research Support|MedPace: Participation on a DRC or DSMB|Medscape/WebMD: Honoraria|MedUpdate: Honoraria|Menarini: Advisor/Consultant|Moderna: Honoraria|Molecular Partners: Advisor/Consultant|MSD: Grant/Research Support|MSD: Honoraria|MSG-ERC: Advisor/Consultant|Mundipharma: Advisor/Consultant|Mundipharma: Grant/Research Support|Mundipharma: Honoraria|Noscendo: Honoraria|Noxxon: Advisor/Consultant|Octapharma: Advisor/Consultant|Octapharma: Grant/Research Support|Pardes: Advisor/Consultant|Partner Therapeutics: Advisor/Consultant|Patent: US18/562644|Paul-Martini-Stiftung: Honoraria|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Pfizer: Honoraria|PSI: Advisor/Consultant|PSI: Participation on a DRC or DSMB|Pulmocide: Participation on a DRC or DSMB|Sandoz: Honoraria|Scynexis: Advisor/Consultant|Scynexis: Grant/Research Support|Seqirus: Advisor/Consultant|Seqirus: Honoraria|Seres: Advisor/Consultant|Shionogi: Advisor/Consultant|Shionogi: Honoraria|streamedup!: Honoraria|The Prime Meridian Group: Advisor/Consultant|Touch Independent: Honoraria|Vitis: Honoraria Christine M. Slover, PharmD, Shionogi Inc.: Employee Sean T. Nguyen, PharmD, Shionogi Inc.: Employee Frank H. Kung, PhD, Shionogi Inc.: Employee Stefano Verardi, MD, Shionogi BV: Employee Christopher M. Longshaw, PhD, Shionogi BV: Employee Stephen Marcella, MD, MPH, Shionogi Inc.: Employee Bin Cai, MD, PhD, Shionogi Inc.: Employee