首页> 外文期刊>The Journal of Antimicrobial Chemotherapy >Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: Results of a randomized, double-blind, phase II trial
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Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: Results of a randomized, double-blind, phase II trial

机译:头孢他啶/ avibactam加甲硝唑与美罗培南治疗住院成人复杂腹腔内感染的疗效和安全性比较研究:一项随机,双盲,II期临床试验的结果

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Objectives: Avibactam, a novel non-β-lactam β-lactamase inhibitor, restores the in vitro activity of ceftazidime against class A, C and some class D β-lactamase-producing pathogens, including those commonly associated with complicated intra-abdominal infections (cIAIs). This randomized, active-controlled, double-blind, Phase II trial (NCT00752219) aimed to evaluate the safety and efficacy of ceftazidime/avibactam plus metronidazole compared with meropenem in hospitalized patients with cIAI. Methods: Adults with confirmed cIAI requiring surgical intervention and antibiotics were randomized 1: 1 to receive intravenously either (i) 2000 mg of ceftazidime plus 500 mg of avibactam plus a separate infusion of 500 mg of metronidazole or (ii) 1000 mg of meropenem plus placebo every 8 h for a minimum of 5 days and a maximum of 14 days. The primary efficacy endpoint was the clinical response in microbiologically evaluable (ME) patients at the test-of-cure (TOC) visit 2 weeks after the last dose of study therapy. Results: Overall, 101 patients received ceftazidime/avibactam plus metronidazole; 102 received meropenem. The median duration of treatment was 6.0 and 6.5 days, respectively. Favourable clinical response at the TOC visit in the ME population was observed in 91.2% (62/68) and 93.4% (71/76) of patients in the ceftazidime/avibactam plus metronidazole and meropenem groups, respectively (observed difference: -2.2%; 95% CI: -20.4%, 12.2%). The incidence of treatment-emergent adverse events was similar for ceftazidime/avibactam plus metronidazole (64.4%) and meropenem (57.8%). Conclusions: Ceftazidime/avibactam plus metronidazole was effective and generally well tolerated in patients with cIAI, with a favourable clinical response rate in the ME population of >90%, similar to that of meropenem.
机译:目的:阿维巴坦是一种新型的非β-内酰胺β-内酰胺酶抑制剂,可恢复头孢他啶对A,C类和某些D类β-内酰胺酶产生病原体的体外活性,包括那些通常与复杂的腹腔内感染相关的病原体( cIAIs)。这项随机,主动控制,双盲的II期临床试验(NCT00752219)旨在评估头孢他啶/阿维巴坦加甲硝唑与美罗培南在住院的cIAI患者中的安全性和有效性。方法:将确诊为cIAI且需要手术干预并使用抗生素的成年人按1:1的比例随机分配,以静脉注射(i)2000 mg头孢他啶加500 mg avibactam加单独输注500 mg甲硝唑或(ii)1000 mg美罗培南每8小时服用安慰剂,至少需要5天,最多14天。主要疗效终点是在最后一剂研究治疗药物治疗后2周进行的微生物学评估(ME)患者在治愈测试(TOC)时的临床反应。结果:总共101例患者接受了头孢他啶/ avibactam加甲硝唑治疗; 102例接受美罗培南。中位治疗时间分别为6.0天和6.5天。头孢他啶/ avibactam联合甲硝唑和美罗培南组的患者中,ME人群中TOC访视的临床反应良好,分别为91.2%(62/68)和93.4%(71/76)(观察到的差异:-2.2% ; 95%CI:-20.4%,12.2%)。头孢他啶/阿维巴坦加甲硝唑(64.4%)和美罗培南(57.8%)的紧急治疗不良事件发生率相似。结论:头孢他啶/ avibactam加甲硝唑对cIAI患者有效且耐受性良好,在ME人群中的临床缓解率> 90%,与美洛培南相似。

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