Clinical phase III comparative study of intravenous levofloxacin and ceftriaxone in community-acquired pneumonia treatment

Shigeru Kohno, Akira Watanabe, Nobuki Aoki, Yoshihito Niki, Junichi Kadota, Jiro Fujita, Katsunori Yanagihara, Mitsuo Kaku, Seiji Hori

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

To evaluate the efficacy and safety of intravenous levofloxacin(LVFX) in adults with community-acquired bacterial but not atypical organismic pneumonia, we conducted a multicenter randomized open-label non-inferiority study using ceftriaxone(CTRX) as a comparator. Subjects were randomized through central registration to be administered LVFX 500 mg once daily or CTRX 1 g twice daily as an intravenous infusion for 7 to 14 days. Clinical efficacy: At the end of treatment, clinical response was 88.5% (92/104) in LVFX-treated and 88.8% (79/89) in CTRX-treated. The intergroup difference was -0.3% (95% confidence interval, -9.3 to 8.7) and non-inferiority of LVFX versus CTRX was established. Microbiologic efficacy: Eradication at the end of treatment was achieved in 96.7% (59/61) treated with LVFX and 97.8% (44/45) treated with CTRX. The intergroup difference was - 1.1% (95% confidence interval, -7.3 to 5.1). Safety: Adverse drug reactions were reported in 53.7% (73/136) treated with LVFX and 56.9% (70/123) treated with CTRX. The intergroup difference was -3.2% (95% confidence interval, -15.4 to 8.9). Our results showed that intravenous LVFX 500 mg once daily is as effective and safe as CTRX 1 g twice daily in treating community-acquired bacterial pneumonia.

Original languageEnglish
Pages (from-to)32-45
Number of pages14
JournalJapanese Journal of Chemotherapy
Volume59
Issue numberSUPPL. 1
Publication statusPublished - 2011 May

Keywords

  • Community-acquired pneumonia
  • Levofloxacin injection
  • Randomized-controlled trial

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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