Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
J Antimicrob Chemother. 2011 Nov;66(11):2632-42. doi: 10.1093/jac/dkr344. Epub 2011 Sep 6.
The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC).
The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7-21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727.
A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP-AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP-AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP-AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP-AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated.
Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs.
RELIEF 研究的主要目的是评估两种连续静脉（iv）/口服方案的疗效和安全性：莫西沙星 iv/口服与哌拉西林/他唑巴坦（TZP）iv 后口服阿莫西林/克拉维酸（AMC）。
该研究采用前瞻性、随机、双盲、多中心设计。根据复杂皮肤和皮肤结构感染（cSSSI）亚型/诊断（大脓肿、糖尿病足感染、伤口感染或感染性缺血性溃疡）、手术干预和疾病严重程度，对年龄≥18 岁的患者进行前瞻性分层。诊断和疾病严重程度基于预定标准，通过反复拍照记录，并由独立的数据审查委员会确认。患者随机接受每日一次 400mg 莫西沙星 iv 治疗，随后每日一次 400mg 莫西沙星口服治疗，或每日三次 4.0/0.5g TZP iv 治疗，随后每日两次 875/125mg AMC 口服治疗 7-21 天。主要疗效变量为治愈测试（TOC）的临床应答（PP 人群）。临床疗效由数据审查委员会根据反复拍照和病例描述进行评估。临床试验注册号：NCT 00402727。
共纳入 813 例患者进行随机分组。PP 人群中莫西沙星和 TZP-AMC 的临床治愈率在 TOC 时相似[320/361（88.6%）与 275/307（89.6%）；P=0.758]和意向治疗（ITT）人群[350/426（82.2%）与 305/377（80.9%）；P=0.632]。因此，莫西沙星与 TZP-AMC 相当。两种治疗方案的细菌学治愈率均较高[莫西沙星：432/497（86.9%）与 TZP-AMC：370/429（86.2%），微生物学有效（MBV）人群]。在 MBV 和 ITT 人群中，莫西沙星在 TOC 时与 TZP-AMC 相当。两种治疗方法均耐受良好。
在 cSSSIs 患者中，每日一次 iv/口服莫西沙星单药治疗与每日三次 iv TZP 治疗后口服 AMC 每日两次治疗在临床和细菌学方面相当。
