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

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.