1. Unveiling results and insights from multinational, multicenter Study of Prescribing patterns and Effectiveness of Ceftolozane/Tazobactam Real-world Analysis (SPECTRA).
- Author
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Soriano A, Paterson DL, Thalhammer F, Kluge S, Viale P, Watanabe AH, Allen M, Akrich B, Wirbel S, Obi EN, Yücel E, and Kaul S
- Abstract
Objectives: Antibacterial-resistant gram-negative hospital-acquired infections result in significant morbidity and mortality. In clinical trials, ceftolozane/tazobactam (C/T) has been effective against these infections; however, real-world findings are limited., Methods: SPECTRA was a global, retrospective, observational inpatient study of adults treated with C/T for ≥48 hours, conducted between 2016 and 2020. The primary objective was to describe real-world utilisation of C/T: socio-demographic, clinical characteristics, prescribing patterns, clinical outcomes, and healthcare resource utilisation in hospitalized patients treated with C/T., Results: In total, 617 patients from 7 countries met inclusion criteria. Most (82.7%) had ≥1 comorbidity. The most common medical conditions where C/T was used were pneumonia (29.5%), sepsis (20.4%), complicated intra-abdominal infection (15.1%), and complicated urinary tract infection (14.4%). The most common pathogens were Pseudomonas aeruginosa (87.4%) and Escherichia coli (8.2%). Median C/T treatment duration was 11 days. Clinical success occurred in 67.3% of patients (including those with 'unknown' status in the denominator). In a separate analysis that excluded those with 'unknown' status, clinical success ranged from 94.1% in patients with bacteraemia to 58.9% with sepsis. Overall, 18.8% of patients had documented microbiologic response. All-cause in-hospital mortality was 21.2%; infection-related mortality was 7.6%. Median hospital length of stay was 42 days (30 days for those who received early C/T therapy [before pathogen identification] vs. 48 days for definitive therapy [after identification])., Conclusions: These data elucidate real-world utilisation and prescribing patterns of C/T in a diverse patient population with complex medical conditions and various profiles of pathogen resistance between 2016 and 2020., Competing Interests: Declaration of interests AHW, ENO, and EY are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. MA is an employee of MSD London, and BA is an employee of MSD France. AS, has received honoraria for lectures and advisory boards from Advance Pharma, Angelini Pharma, Pfizer, Menarini, MSD, Shionogi, and Gilead. AS has received research grants from Gilead and Pfizer. DLP has research funding from Shionogi, Merck, bioMerieux, BioVersys and Pfizer and has received consulting fees from the AMR Action Fund, CARB-X, Aurobac, Pfizer, Merck, Cepheid, bioMerieux and Spero. FT has received honoraria for lectures from Advanz Pharma, Astro Pharma, InfectoPharm, Menarini, MSD, Pfizer, and Shionogi. SKl received research support from CytoSorbents and Daiichi Sankyo. SKl also received lecture fees from ADVITOS, Biotest, Daiichi Sankyo, Fresenius Medical Care, Gilead, Mitsubishi Tanabe Pharma, MSD, Pfizer, Shionogi, and ZOLL. SKl received consultant fees from Fresenius Medical Care, Gilead, MSD, and Pfizer. PV received lecture fees from Advanz Pharma, bioMérieux, Gilead, Menarini Group, MSD, Pfizer, and MSD. SW is a full-time employee of ICON Plc, which was contracted by Merck & Co. Inc. as part of MSD (UK) Limited. SKa received lecture fees from Jafron, GlaxoSmithKline, Pfizer, AstraZeneca, Chiesi, MSD, Gilead, and research support from MSD., (Copyright © 2025. Published by Elsevier Ltd.)
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- 2025
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