Efficacy of oral fleroxacin in bone and joint infections.

Bone and joint infections have traditionally required long-term parenteral antimicrobial therapy, which is often expensive and inconvenient. Because of their excellent absorption and tissue penetration, oral quinolones may provide an alternative to parenteral therapy. This multicenter study was designed to evaluate the efficacy and safety of oral fleroxacin in osteomyelitis and septic arthritis. A total of 96 patients with either septic arthritis or acute or chronic osteomyelitis from 17 U.S. centers were enrolled in a noncomparative study using oral fleroxacin 400 mg per day. Patients with implantable devices were excluded. Proof of infection for evaluability required clinical findings in addition to bacteriologic recovery of a susceptible organism from synovial fluid or bone. Treatment lasted 2-12 weeks. Clinical and bacteriologic outcomes were judged at the conclusion of therapy and in the 6-week follow-up period. A total of 30 patients qualified for efficacy analysis (26 osteomyelitis, 4 septic arthritis). Bacteriologic cure was achieved in 77% of the osteomyelitis group and 50% of the septic arthritis group. Clinical cures were reported in 54% of the osteomyelitis group and 50% of the septic arthritis group. Staphylococcus aureus was the most frequently recovered pathogen (62% evaluable cases). Safety was evaluated in 96 patients. The most common side effects were nausea, vomiting, and skin reactions. Oral fleroxacin may be a safe, effective, and certainly less expensive alternative to standard intravenous antimicrobial therapy in patients with bone and joint infections.