Cefepime–Taniborbactam in Complicated Urinary Tract Infection

头孢吡肟 医学 美罗培南 菌血症 泌尿系统 随机化 人口 铜绿假单胞菌 随机对照试验 B组 外科 内科学 头孢他啶 微生物学 抗生素 抗生素耐药性 生物 遗传学 环境卫生 细菌
作者
Florian Wagenlehner,Leanne B. Gasink,Paul C. McGovern,Greg Moeck,Patrick McLeroth,MaryBeth Dorr,Aaron Dane,Tim Henkel
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:390 (7): 611-622 被引量:39
标识
DOI:10.1056/nejmoa2304748
摘要

BackgroundCarbapenem-resistant Enterobacterales species and multidrug-resistant Pseudomonas aeruginosa are global health threats. Cefepime–taniborbactam is an investigational β-lactam and β-lactamase inhibitor combination with activity against Enterobacterales species and P. aeruginosa expressing serine and metallo-β-lactamases.MethodsIn this phase 3, double-blind, randomized trial, we assigned hospitalized adults with complicated urinary tract infection (UTI), including acute pyelonephritis, in a 2:1 ratio to receive intravenous cefepime–taniborbactam (2.5 g) or meropenem (1 g) every 8 hours for 7 days; this duration could be extended up to 14 days in case of bacteremia. The primary outcome was both microbiologic and clinical success (composite success) on trial days 19 to 23 in the microbiologic intention-to-treat (microITT) population (patients who had a qualifying gram-negative pathogen against which both study drugs were active). A prespecified superiority analysis of the primary outcome was performed after confirmation of noninferiority.Download a PDF of the Research Summary.ResultsOf the 661 patients who underwent randomization, 436 (66.0%) were included in the microITT population. The mean age of the patients was 56.2 years, and 38.1% were 65 years of age or older. In the microITT population, 57.8% of the patients had complicated UTI, 42.2% had acute pyelonephritis, and 13.1% had bacteremia. Composite success occurred in 207 of 293 patients (70.6%) in the cefepime–taniborbactam group and in 83 of 143 patients (58.0%) in the meropenem group. Cefepime–taniborbactam was superior to meropenem regarding the primary outcome (treatment difference, 12.6 percentage points; 95% confidence interval, 3.1 to 22.2; P=0.009). Differences in treatment response were sustained at late follow-up (trial days 28 to 35), when cefepime–taniborbactam had higher composite success and clinical success. Adverse events occurred in 35.5% and 29.0% of patients in the cefepime–taniborbactam group and the meropenem group, respectively, with headache, diarrhea, constipation, hypertension, and nausea the most frequently reported; the frequency of serious adverse events was similar in the two groups.ConclusionsCefepime–taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a safety profile similar to that of meropenem. (Funded by Venatorx Pharmaceuticals and others; CERTAIN-1 ClinicalTrials.gov number, NCT03840148.) Quick Take Cefepime–Taniborbactam for Complicated UTI 2m 19s
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