Vol.53 No.3 March 2005

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

Jirô Arata¹⁾, Hiroshi Shimizu²⁾, Shinichi Watanabe³⁾, Yoshiki Miyachi⁴⁾, Keiji Iwatsuki⁵⁾, Masutaka Furue⁶⁾, Makoto Ono⁷⁾, Tomohide Sato⁷⁾ and Masaru Iwasaki⁷⁾

¹⁾Yoyukai Nakashima Hospital, 1878 Senoo, Okayama, Japan
²⁾Department of Dermatology, Graduate School of Medicine, Hokkaido University
³⁾Department of Dermatology, School of Medicine, Teikyo University
⁴⁾Department of Dermatology, Graduate School of Medicine, Kyoto University
⁵⁾Department of Dermatology, Graduate School of Medicine and Dentistry, Okayama University
⁶⁾Department of Dermatology, Graduate School of Medical Sciences, Kyushu University
⁷⁾Aventis Pharma Ltd.

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.

Key word

telithromycin, skin and soft tissue infection, clinical efficacy

Received

December 16, 2004

Accepted

February 15, 2005

Jpn. J. Chemother. 53 (3): 207-224, 2005