Efficacy, safety, and pharmacokinetics of telithromycin in patients with skin and soft tissue infections

Jirô Arata, Hiroshi Shimizu, Shinichi Watanabe, Yoshiki Miyachi, Keji Iwatsuki, Masutaka Furue, Makoto Ono, Tomohide Sato, Masaru Iwasaki

Research output: Contribution to journalArticlepeer-review

Abstract

A clinical pharmacological study to evaluate telithromycin (TEL), an oral ketolide antibiotic, for its skin penetration, and a phase III Open clinical study of administration of TEL 600 mg once daily for 5 days to patients with superficial skin infection, secondary infection, and miscellaneous abscesses were conducted. 1. Penetration of skin tissues In the 13 patients evaluated, mean skin concentration at 5 hours 20 minutes to 6 hours 35 minutes was 0.64 μg/g and plasma concentrations at the almost same time was 0.38 μg/mL after a single oral dose of TEL 600 mg, and the skin concentration/plasma concentration ratio was 1.50. 2. Clinical outcome In the 80 patients evaluated for clinical outcome, clinical efficacy was 81.3% (65/80). Clinical efficacy for superficial skin infection, secondary infection and miscellaneous abscesses was 96.0% (24/25), 85.7% (18/21), and 67.6% (23/34). 3. Bacteriological outcome The bacteriological outcome was evaluated in 78 patients, and bacteriological efficacy in 67 patients, excluding 11 patients for whom the bacteriological outcome could not be determined, was 88.1% (59/67). Total eradication for all pathogens isolated prior to administration was 93.0% (106/114). 4. Safety Safety was evaluated in 98 patients. The incidence of side effects in 95, excluding 3 for whom safety was not determined, was 30.5% (29/95). All side effects observed were mild or moderate. Findings thus suggest that TEL penetrated skin well and that the administration of TEL 600 mg once daily for 5 days is clinically effective and safe in the treatment of skin and soft tissue infection.

Original languageEnglish
Pages (from-to)207-224
Number of pages18
JournalJapanese Journal of Chemotherapy
Volume53
Issue number3
Publication statusPublished - Mar 2005

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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