Comparison of oral fleroxacin with oral amoxicillin/clavulanate for treatment of skin and soft tissue infections.

Oral fleroxacin, 400 mg once a day, and oral amoxicillin/clavulanate potassium (AMX/CP), 400 mg/125 mg three times a day, administered for 4-21 days, were compared for efficacy and safety in the treatment of skin and soft tissue infections. A total of 113 patients were enrolled in a multicenter, randomized, double-blind trial; 57 were assigned to fleroxacin and 56 to AMX/CP. A total of 22 and 33 patients in the fleroxacin and AMX/CP groups, respectively, were evaluable for efficacy. The most common diagnoses were skin abscess (14; 62%) and wound infections (5; 23%) in the fleroxacin group and skin abscess (17; 52%) and skin ulcer (9; 27%) in the AMX/CP group. A total of 20 (91%) of the fleroxacin-treated patients and 29 (88%) of the AMX/CP-treated patients were bacteriologically cured (two fleroxacin- and one AMX/CP-treated patients developed super-infection). The eradication rate for Staphylococcus aureus was 100% (11 of 11) in the fleroxacin group and 89% (17 of 19) in the AMX/CP group; 18 (82%) of the fleroxacin group and 25 (76%) of the AMX/CP group were clinically cured. Adverse events were seen in 22% (12 of 54) of the fleroxacin group and 25% (13 of 53) of the AMX/CP group. None were serious. Bacteriologic and clinical cure rates and safety results for the two groups were similar. The small sample size precluded statistical analysis at the 95% confidence level.