Chaudhary Manu, Ayub Shiekh Gazalla, Mir Mohd Amin
Department of Clinical Research, Venus Remedies, Panchkula, Haryana, India.
J Glob Infect Dis. 2018 Oct-Dec;10(4):188-195. doi: 10.4103/jgid.jgid_98_17.
The aim of this study was to determine the clinical outcome, microbiological outcome and safety profile of CSE-1034, a novel combination of Ceftriaxone, Sulbactam and EDTA in patients with complicated urinary tract infections (cUTI).
This was a randomized, controlled, open-labeled Phase-3 trial with the primary objective of assessing the efficacy and safety of CSE-1034 versus Ceftriaxone for the empirical treatment of cUTI. Adult cUTI patients were randomized to receive either intravenous dose of CSE-1034 or Ceftriaxone. The primary end point was composite cure rate (clinical response and bacterial eradication) in mMITT population at test of cure (TOC) visit. Secondary measures included verification of primary endpoint across other visits in different population sets, safety of patients and treatment duration.
Overall, 204 patients were enrolled in the study and received one of the two treatments. At primary endpoint (TOC visit), the composite cure rate was much higher in CSE-1034 treatment arm compared to Ceftriaxone arm i.e. 97% (68/70) vs 83% (58/71) (treatment difference 12.6%; 95% CI: 5.9% to 26.4%). The adverse events (AEs) rates reported in two treatment arms were 21% in CSE-1034 and 36% in Ceftriaxone groups. Additionally, the treatment duration in CSE-1034 arm was significantly less ( < 0.05).
CSE-1034 3 g every 24 h showed a high favorable clinical and bacteriological response, and 95% CI around the treatment difference prove the superiority of CSE-1034 vs. Ceftriaxone for the treatment of cUTI. Therefore, CSE-1034 provides an effective alternative in the treatment of patients with cUTI.
本研究旨在确定头孢曲松、舒巴坦和乙二胺四乙酸的新型组合CSE-1034用于治疗复杂性尿路感染(cUTI)患者的临床疗效、微生物学疗效及安全性。
这是一项随机、对照、开放标签的3期试验,主要目的是评估CSE-1034与头孢曲松对cUTI进行经验性治疗的疗效和安全性。成年cUTI患者被随机分配接受静脉注射剂量的CSE-1034或头孢曲松。主要终点是在治愈试验(TOC)访视时,mMITT人群中的综合治愈率(临床反应和细菌清除)。次要指标包括在不同人群组的其他访视中对主要终点的验证、患者安全性和治疗持续时间。
总体而言,204名患者参与了本研究并接受了两种治疗中的一种。在主要终点(TOC访视)时,CSE-1034治疗组的综合治愈率远高于头孢曲松组,即97%(68/70)对83%(58/71)(治疗差异12.6%;95%置信区间:5.9%至26.4%)。两个治疗组报告的不良事件(AE)发生率分别为:CSE-1034组21%,头孢曲松组36%。此外,CSE-1034组的治疗持续时间显著更短(<0.05)。
每24小时3克的CSE-1034显示出良好的临床和细菌学反应,治疗差异的95%置信区间证明了CSE-1034在治疗cUTI方面优于头孢曲松。因此,CSE-1034为治疗cUTI患者提供了一种有效的替代方案。