2022年10月21日

資料來源:披露:McGovern受雇於Venatorx Pharmaceuticals。其他作者沒有報告相關的財務披露。添加主題到電子郵件提醒收到電子郵件時，有新的文章發表請提供您的電子郵件地址收到電子郵件時，有新的文章發表。請稍後再試。如果您仍然有此問題，請聯係customerservice@slackinc.com。根據IDWeek提供的數據，Cefepime-taniborbactam在治療包括急性腎盂腎炎在內的複雜尿路感染方麵，在統計學上優於美羅培南。Venatorx製藥公司醫學科學高級副總裁保羅·c·麥戈文醫學博士及其同事寫道:“耐碳青黴烯類腸杆菌和耐多藥銅綠假單胞菌是全球抗菌素耐藥性威脅。”McGovern PC，等。摘要731年。發表於:IDWeek; Oct. 19- 23, 2022. Washington (hybrid meeting). A possible treatment against these resistant pathogens seen with complicated UTIs (cUTIs), including acute pyelonephritis (AP), is cefepime-taniborbactam (FTB) — an investigational beta-lactam/beta-lactamase inhibitor combination. Through Cefepime Rescue with Taniborbactam in cUTI (CERTAIN-1) — a randomized, double-blind, double-dummy, phase 3 study comparing FTB with meropenem (MEM) in adults hospitalized with cUTI or AP, McGovern and colleagues evaluated the safety and efficacy of FTB. According to the study, patients were randomly assigned 2:1 to receive either 2.5 g of FTB via IV or 1 g of MEM via IV for 7 days or up to 14 days in patients with bacteremia. The primary endpoint was the composite response at the test of cure (TOC) visit in the micro-intent-to-treat (microITT) population, which McGovern described as a cohort of patients who have either one or two qualifying gram-negative pathogens present, greater than 105 colony-forming units/mL of urine, and the pathogen has to be sensitive to both treatments in the trial. In total, 661 patients were randomly assigned, and 436 patients (66%) were included in the microITT population, including 42.2% with AP and 57.8% with cUTI. Study data showed that composite success was achieved in 70% and 58% of FTB and MEM patients, respectively, although they found that FTB was “statistically superior” to MEM for the primary endpoint at the TOC (treatment difference FTB-MEM = 11.9%; 95% CI, 2.4-21.6). Additionally, researchers observed treatment-emergent adverse events in 35.5% of FTB patients and 29% of MEM patients. The most common adverse events were headache (FTB 6.1%, MEM 3.7%) and diarrhea (FTB 4.1%, MEM 2.3%). During a presentation at IDWeek, McGovern said that based on the success of CERTAIN-1, the data will be used as part of a new drug application package to the FDA in the first half of 2023. “We hope that it will be approved and available for use by clinicians sometime early in 2024,” he said. Read more about