Clinical phase III comparative study on garenoxacin versus levofloxacin in patients with bacterial pneumonia

Hiroyuki Kobayashi, Akira Watanabe, Nobuki Aoki, Shigeki Odagiri, Shin Kawai, Yoshihito Niki, Shigeru Kohno, Atsushi Saito

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

The clinical efficacy and safety of garenoxacin mesilate hydrate(GRNX), a novel des-fluoro quinolone, and levofloxacin (LVFX) for bacterial pneumonia were investigated double blind. Clinical efficacy was observed at the end day of treatment, and comparing the results of the 7th day after treatment completion in European and South American studies, patients were treated with either GRNX 400 mg once daily (GRNX group) or LVFX 100 mg three times daily (LVFX group) for 10 days. The efficacy rates at the end day of treatment were 99.1% (111/112) in the GRNX group and 94.9% (82/87) in the LVFX group. The noninferiority of GRNX against LVFX was demonstrated. The efficacy rates at the 7th day after treatment completion were 94.9% (94/99) in the GRNX group and 92.8% (77/83) in the LVFX group. Bacteriological efficacy was 100% in both the GRNX group (59/59) and the LVFX group (40/40). The bacteriological eradication rates at the 7th day after treatment completion were 100% (50/50) in the GRNX group and 86.8% (33/38) in the LVFX group. The incidence of drug-induced adverse events, including laboratory abnormalities was 35.6% (48/135) in the GRNX group and 27.1% (32/118) in the LVFX group, indicating no significant difference between groups. The sort and grade of adverse events were also similar between groups, and no strange event was observed. The efficacy rate of GRNX at the 7th day after treatment completion was 89.9% (89/99) in European and South American studies. The clinical efficacy and safety which were observed in our study were similar to those of overseas results. Summarizing this study, GRNX, a 400 mg oral dose once daily for 10 days, should be clinically a very useful medication in the treatment of bacterial pneumonia.

Original languageEnglish
Pages (from-to)127-143
Number of pages17
JournalJapanese Journal of Chemotherapy
Volume55
Issue numberSUPPL. 1
Publication statusPublished - 2007 Oct
Externally publishedYes

Keywords

  • Double blind study
  • Garenoxacin
  • Levofloxacin
  • Pneumonia

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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