Double-blind randomized study of oral temafloxacin and cefadroxil in patients with mild to moderately severe bacterial skin infections.

A randomized, double-blind, multicenter study was conducted in 374 patients to evaluate the safety and efficacy of a 7-10-day regimen of oral temafloxacin (600 mg b.i.d.) or oral cefadroxil (500 mg b.i.d.) in the treatment of mild to moderate staphylococcal or streptococcal infection of the skin or skin structure. Specimens from the infected skin lesion were obtained for culture. A dermatologic assessment was made within 48 hours of starting therapy, 0-48 hours post-treatment, and once during the 5-9 days following the last dose of study drug. The most common diagnoses were abscess, superficial skin infection, cellulitis, and infection of the hair follicle/sweat gland. Clinical response rates exceeded 95% in both the temafloxacin and cefadroxil groups. A higher bacterial eradication rate was demonstrated in the temafloxacin-treated patients (91%) than in those receiving cefadroxil (84%). This was statistically significant in the subset of infections caused by Staphylococcus epidermidis (100% versus 81%, respectively; p = 0.032). Both regimens were well tolerated. These results indicate that temafloxacin is useful in the treatment of mild to moderate skin and skin structure infections caused by staphylococci or streptococci.