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替加环素对参与复杂性皮肤和皮肤结构感染及复杂性腹腔内感染治疗的3期临床试验患者分离株的体外活性。

In vitro activity of tigecycline against isolates from patients enrolled in phase 3 clinical trials of treatment for complicated skin and skin-structure infections and complicated intra-abdominal infections.

作者信息

Bradford Patricia A, Weaver-Sands D Tasha, Petersen Peter J

机构信息

Infectious Diseases Discovery Research, Wyeth Research, Pearl River, NY 10965, USA.

出版信息

Clin Infect Dis. 2005 Sep 1;41 Suppl 5:S315-32. doi: 10.1086/431673.

Abstract

The in vitro activity of tigecycline was evaluated against 4913 baseline pathogens isolated from 1986 patients enrolled in 4 pivotal phase 3 clinical trials. The trials, which were conducted in 38 countries worldwide, involved patients with complicated skin and skin-structure infections or complicated intra-abdominal infections. Tigecycline was active against the most prevalent pathogens for each infection type, including gram-positive and gram-negative strains of both aerobic and anaerobic bacteria (MICs, < or =2 microg/mL for most pathogens). The spectrum of activity of tigecycline included important pathogens, such as Staphylococcus aureus (including methicillin-resistant S. aureus), Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, and Bacteroides fragilis. A few genera, such as Pseudomonas aeruginosa and members of the tribe Proteeae, were generally less susceptible to tigecycline than were other gram-negative pathogens. The susceptibility of the pathogens to tigecycline was similar for isolates obtained from patients enrolled in the studies of complicated skin and skin-structure infection or of complicated intra-abdominal infection. For most pathogens, the susceptibility to tigecycline was similar across all geographic regions. The excellent expanded broad-spectrum activity of tigecycline demonstrated in vitro against clinical isolates confirmed its potential utility for pathogens associated with complicated skin and skin-structure infections or complicated intra-abdominal infections.

摘要

对从参与4项关键3期临床试验的1986例患者中分离出的4913株基线病原体进行了替加环素的体外活性评估。这些试验在全球38个国家进行,涉及患有复杂性皮肤和皮肤结构感染或复杂性腹腔内感染的患者。替加环素对每种感染类型的最常见病原体均有活性,包括需氧菌和厌氧菌的革兰氏阳性和革兰氏阴性菌株(大多数病原体的MICs≤2μg/mL)。替加环素的活性谱包括重要病原体,如金黄色葡萄球菌(包括耐甲氧西林金黄色葡萄球菌)、化脓性链球菌、大肠杆菌、肺炎克雷伯菌和脆弱拟杆菌。一些菌属,如铜绿假单胞菌和变形杆菌属成员,通常比其他革兰氏阴性病原体对替加环素的敏感性更低。从参与复杂性皮肤和皮肤结构感染或复杂性腹腔内感染研究的患者中分离出的病原体对替加环素的敏感性相似。对于大多数病原体,所有地理区域对替加环素的敏感性相似。替加环素在体外对临床分离株表现出的出色的广谱活性证实了其对与复杂性皮肤和皮肤结构感染或复杂性腹腔内感染相关病原体的潜在效用。

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