Clinical response of levofloxacin 500 mg qd to respiratory tract infection

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

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)


We evaluated the efficacy and safety of LVFX 500 mg qd administered for 7 days to 152 Japanese patients with respiratory tract infection in an open uncontrolled clinical study. We also studied the possible correlation of the incidence of adverse event and adverse drug reactions(ADRs) with individual pharmacokinetic (PK) parameters estimated by the Bayesian method. Clinical efficacy was 95.1% (136/143 patients), and bacteriological efficacy 100% (45/45 patients). All causative organisms (50 strains), including those commonly separated, i.e., Streptococcus pneumoniae, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Staphylococcus aureus, and Klebsiella pneumoniae, were eradicated with treatment in patients eligible for bacteriological efficacy assessment. ADRs were reported in 60 patients at an incidence of 39.5%. A liver disorder was reported as a serious adverse drug reaction in a patient administered LVFX. The patient discontinued taking LVFX and recovered through hospitalization and medical treatment No ADRs were severe and all had already been reported as LVFX ADRs. Neither the incidence of adverse events nor ADRs was exposure-dependent in the LVFX plasma concentration range observed in this study. In conclusion, LVFX 500 mg qd appears to have efficacy comparable or superior to that of the current standard dosage and presents no significant safety problem.

Original languageEnglish
Pages (from-to)20-33
Number of pages14
JournalJapanese Journal of Chemotherapy
Issue numberSUPPL. 2
Publication statusPublished - 2009 Jul


  • Clinical study
  • Levofloxacin
  • Once-a-day
  • PK-PD
  • Respiratory tract infection

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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