Fleroxacin 400 mg once daily versus ofloxacin 400 mg twice daily in skin and soft tissue infections

Abstract

The efficacy and safety of 10 days' oral treatment with fleroxacin 400 mg once daily were compared with those of ofloxacin 400 mg twice daily in adults with skin and soft tissue infections. The most common diagnoses were skin abscess, cellulitis and wound infection. The most commonly-isolated pathogens were Staphylococcus aureus, Staphylococcus epidermidis and other coagulase-negative staphylococci. Overall bacteriological cure rates in patients with susceptible pathogens were 89% for 158 fleroxacin-treated patients and 97% for 157 ofloxacin-treated patients (treatment difference 8%; 95% confidence intervals 2-14%; p < 0.05). Clinical cure rates were 78% for fleroxacin and 83% for ofloxacin (treatment difference 5%; 95% confidence intervals-5-14%, not statistically significant). The overall safety profiles were similar and the most frequently reported events were insomnia, headache, dizziness, and digestive system disorders. More fleroxacin-treated patients experienced phototoxicity and treatment-limiting adverse events. In conclusion, compared to twice-daily ofloxacin, fleroxacin had similar clinical efficacy and the advantage of once-a-day dosing, but with slightly lower bacteriological cure rate and a higher rate of treatment-limiting adverse events.