Vol.53 No.3 March 2005

Clinical evaluation of telithromycin in patients with skin and soft tissue infections Phase III double-blind comparative study of telithromycin versus cefdinir

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

The efficacy and safety of telithromycin (TEL), an oral ketolide antibiotic, was evaluated in a double-blind, parallel-group, noninferiority comparative study with cefdinir (CFDN) as the control drug under minimized randomization method. Patients with deep-seated skin infections were assigned either to the TEL group (TEL 600 mg once daily for 5 days) or the CFDN group (CFDN 100 mg 3 times daily for 5 days).
1. Clinical outcome
In the 228 patients evaluated for clinical outcome, clinical efficacy was 88.9% (104/117) in the TEL group and 82.9% (92/111) in the CFDN group, and the noninferiority of TEL compared to CFDN was confirmed.
2. Bacteriological outcome
The bacteriological outcome was evaluated in 223 patients, and bacteriological efficacy in 143 patients, excluding 80 patients for whom the bacteriological outcome could not be determined, was 98.6% (71/72) in the TEL group and 93.0% (66/71) in the CFDN group. Total eradication, the sum of eradications for all causative pathogen isolated prior to administration, was 100.0% (114/114) in the TEL group and 94.1% (96/102) in the CFDN group.
3. Safety
Safety was evaluated in 245 patients. The incidence of side effects in 242, excluding 3 for whom safety could not be determined, was 30.6% (37/121) in the TEL group and 35.5% (43/121) in the CFDN group, with no significant difference between groups.
Findings thus suggest that TEL 600 mg once daily for 5 days is as clinically effective and safe as CFDN 100 mg 3 times daily for 5 days in the management of skin and soft tissue infection.

Key word

telithromycin, cefdinir, skin and soft tissue infection, phase III clincal study

Received

December 16, 2004

Accepted

January 18, 2005

Jpn. J. Chemother. 53 (3): 183-206, 2005