[Translation] A randomized, phase II/III two-phase clinical study evaluating the efficacy, safety, and tolerability of enlacycline compared with moxifloxacin in adult subjects with community-acquired bacterial pneumonia (CABP)
阶段1:综合评价依拉环素两个不同给药剂量和频次在CABP受试者的安全性、有效性和药代动力学特征,根据以上结果综合评估并确定阶段2中依拉环素组的给药剂量和频次。 阶段2:
主要目的:评价依拉环素与莫西沙星的mITT人群在TOC访视时的临床疗效
次要目的:
评价依拉环素组与莫西沙星组的
i.ITT和CE人群在TOC访视时的临床疗效
ii.ITT和mITT人群的早期临床应答(ECR)
iii.ITT、mITT和CE人群在EOT访视的临床疗效
iv.m-mITT和ME人群在EOT和TOC访视时的微生物学疗效和综合疗效
v.安全性分析人群中的安全性和耐受性 探索性目的:评价依拉环素组与莫西沙星组mITT、CE人群中在首剂给药后28天内的全因死亡率
[Translation] Phase 1: Comprehensively evaluate the safety, efficacy and pharmacokinetic characteristics of two different doses and frequencies of enlacycline in CABP subjects, and comprehensively evaluate and determine the enracycline group in phase 2 based on the above results. dose and frequency of administration. Stage 2:
Main purpose: To evaluate the clinical efficacy of enlacycline and moxifloxacin in mITT population at TOC visit
Secondary purpose:
Evaluate the effect of enlacycline group and moxifloxacin group
i. Clinical outcomes of the ITT and CE populations at the TOC visit
ii. Early clinical response (ECR) in ITT and mITT populations
iii. Clinical efficacy of ITT, mITT and CE population at EOT visit
iv. Microbiological and composite outcomes at EOT and TOC visits in m-mITT and ME populations
v. Safety and tolerability in the safety analysis population Exploratory purpose: To evaluate all-cause mortality within 28 days after the first dose in the mITT and CE populations in the enlacycline and moxifloxacin groups