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 20minutes to 6 hours 35 minutes was 0.64μg/g and plasma concentrations at the almost same time was 0.38μg/mL after a single oral dose of TEL 600mg, 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.
