A pilot study of oral fleroxacin given once daily in patients with bone and joint infections.

The object of this open-label, noncomparative, multicenter study was to evaluate the efficacy and safety of 400 mg of fleroxacin administered orally once daily for 2-12 weeks to patients with bone and joint infections (osteomyelitis, septic arthritis, and prosthetic joint infection). A total of 90 adult patients (56 men and 34 women) were treated at 11 centers. Patients returned on days 5-9 of treatment, subsequently every 2 weeks during treatment, and 0-3 days and 28-42 days (compulsory follow-up) after treatment for assessment of bacteriologic, clinical, and safety parameters. A total of 19 patients (13 with osteomyelitis, 5 with septic arthritis, and 1 with prosthetic joint infection) were bacteriologically evaluable. Staphylococcus aureus was the predominant pathogen isolated in all evaluable infections. Of the 13 patients with osteomyelitis, 11 (85%) were bacteriologically cured and 10 (77%) were clinically cured. Three of the five patients with septic arthritis and the single patient with a prosthetic joint infection were both bacteriologically and clinically cured. Clinical adverse events related to fleroxacin were reported by 25 (28%) of the 90 patients. Most of these events involved the digestive system (primarily constipation and nausea) and the central nervous system (primarily insomnia and headache). The majority of these were of mild or moderate intensity and occurred during the first 2 weeks of treatment. Adverse events led to premature discontinuation of treatment in seven patients. Bone and joint infections continue to represent a therapeutic challenge. Treatment is based mainly on surgical procedures (drainage, sequestrectomy, ablation of implants, and implantation of cement impregnated with antibiotics) and on parenteral administration of antibiotics, requiring hospitalization of the patient. Fleroxacin, a new fluoroquinolone, has proven in vitro activity against bacteria involved in bone and joint infections. Its oral, once-daily administration, which eliminates hospitalization and its attendant costs, makes this drug an effective outpatient treatment of bone and joint infections.