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在成人社区获得性细菌性肺炎(CABP)患者中,比较 delafloxacin 与 moxifloxacin 针对非典型细菌呼吸道病原体的疗效:来自 Delafloxacin 3 期 CABP 试验的数据。

Efficacy of delafloxacin versus moxifloxacin against atypical bacterial respiratory pathogens in adults with community-acquired bacterial pneumonia (CABP): Data from the Delafloxacin Phase 3 CABP Trial.

机构信息

Melinta Therapeutics, Morristown, NJ, USA.

出版信息

Int J Infect Dis. 2020 Aug;97:374-379. doi: 10.1016/j.ijid.2020.06.018. Epub 2020 Jun 10.

DOI:10.1016/j.ijid.2020.06.018
PMID:32534142
Abstract

OBJECTIVES

To report atypical pathogens from clinical trial data comparing delafloxacin to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia (CABP).

METHODS

Multiple diagnostic methods were employed to diagnose atypical infections including culture, serology, and urinary antigen.

RESULTS

The microbiological intent-to-treat (MITT) population included 520 patients; 30% had an atypical bacterial pathogen identified (156/520). Overall, 13.1% (68/520) had a monomicrobial atypical infection and 2.3% (12/520) had polymicrobial all-atypical infections. Among patients with polymicrobial infections, Streptococcus pneumoniae was the most frequently occurring co-infecting organism and Chlamydia pneumoniae was the most frequently occurring co-infecting atypical organism. For Mycoplasma pneumoniae and Legionella pneumophila, serology yielded the highest number of diagnoses. Delafloxacin and moxifloxacin had similar in vitro activity against M. pneumoniae and delafloxacin had greater activity against L. pneumophila. Two macrolide-resistant M. pneumoniae isolates were recovered. No fluoroquinolone-resistant M. pneumoniae were isolated. The rates of microbiological success (documented or presumed eradication) at test-of-cure were similar between the delafloxacin and moxifloxacin groups. There was no evidence of a correlation between minimum inhibitory concentration (MIC) and outcome; a high proportion of favorable outcomes was observed across all delafloxacin baseline MICs.

CONCLUSIONS

Delafloxacin may be considered a treatment option as monotherapy for CABP in adults, where broad-spectrum coverage including atypical activity is desirable.

摘要

目的

报告临床试验数据中比较达拉沙星和莫西沙星治疗成人社区获得性细菌性肺炎(CABP)的非典型病原体。

方法

采用多种诊断方法诊断非典型感染,包括培养、血清学和尿抗原。

结果

微生物学意向治疗(MITT)人群包括 520 例患者;30%(156/520)确定了非典型细菌病原体。总体而言,13.1%(68/520)有单一微生物非典型感染,2.3%(12/520)有多微生物全部非典型感染。在多微生物感染患者中,肺炎链球菌是最常发生的合并感染病原体,肺炎衣原体是最常发生的合并非典型病原体。对于肺炎支原体和嗜肺军团菌,血清学检测产生了最多的诊断。达拉沙星和莫西沙星对肺炎支原体具有相似的体外活性,而达拉沙星对嗜肺军团菌具有更强的活性。分离出两株耐大环内酯类的肺炎支原体。未分离出耐氟喹诺酮的肺炎支原体。在治愈测试时,微生物学疗效(记录或推测清除)的成功率在达拉沙星和莫西沙星组之间相似。没有证据表明最小抑菌浓度(MIC)与结果之间存在相关性;在所有达拉沙星基线 MIC 中,观察到了相当比例的有利结果。

结论

达拉沙星可被视为成人 CABP 单药治疗的一种治疗选择,在需要广谱覆盖包括非典型病原体的情况下。

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