Efficacy and safety of gemifloxacin in the treatment of community-acquired pneumonia: a randomized, double-blind comparison with trovafloxacin

被引:48
作者
File, TM
Schlemmer, B
Garau, J
Cupo, M
Young, C
机构
[1] Akron Infect Dis Inc, Summa Hlth Syst, Akron, OH 44304 USA
[2] Hosp Mutua Terassa, Barcelona, Spain
[3] Hop St Louis, Paris, France
[4] Smith Kline Beecham, Collegeville, PA USA
关键词
D O I
10.1093/jac/48.1.67
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
This multicentre, randomized, double blind, parallel group study compared the efficacy and safety of gemifloxacin (320 mg once daily) with trovafloxacin (200 mg once daily) in 571 patients with community-acquired pneumonia (CAP). Although treatment was given routinely for 7 days it could be extended to 14 days; two-thirds of patients were treated for 7 days. High clinical success rates were noted at follow-up in the per-protocol population in both the gemifloxacin group (95.8%) and the trovafloxacin group (93.6%), non-inferiority with 95% CI. In the intent-to-treat population, the clinical success rate at follow-up was significantly superior for gemifloxacin (87.6%) compared with trovafloxacin (81.1%; 95% CI 0.5, 12.4). The pathogens identified most commonly at presentation were Mycoplasma pneumoniae and Streptococcus pneumoniae. Gemifloxacin eradicated 100% of S. pneumoniae. One bacteraemic isolate of S. pneumoniae was associated with clinical failure in the trovafloxacin group (MIC of trovafloxacin 8 mg/L). Gemifloxacin was well tolerated and the incidence of transient liver function abnormalities was very low: Gemifloxacin is an effective and well-tolerated treatment for patients with CAP.
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页码:67 / 74
页数:8
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