Sparfloxacin for the treatment of acute bacterial maxillary sinusitis documented by sinus puncture

Purpose: To evaluate the efficacy and safety of sparfloxacin in the treatme nt of patients with acute bacterial maxillary sinusitis, the microbiologic etiology of which was determined by maxillary sinus puncture. Patients and Methods: Two hundred fifty-three patients enrolled in the open , noncomparative trial received sparfloxacin as a 400-mg loading dose follo wed by 200 mg once daily doses for a total of 10 days. One hundred ninety-e ight patients were clinically evaluable and 82 were also bacteriologically evaluable. All treated patients were included in the safety analysis. Overa ll success was determined based on clinical success (resolution or reductio n of signs and symptoms and sinus x-rays) and bacteriologic success (eradic ation and presumed eradication of baseline pathogens obtained by maxillary sinus puncture and aspiration). Results: Overall success in the bacteriologically evaluable population at t est-of-cure was 91.5% [75/82; 95% confidence interval (85.4%, 97.5%)]. For all pathogens, the eradication rate was 93.2% (109/117 baseline pathogens); individual pathogen eradication rates were 88.9% (16/18) for S. pneumoniae (including those strains exhibiting decreased susceptibility to penicillin ); and 100% for H. influenzae (17/17), S, aureus (14/14), and M. catarrhali s (11/11). The majority of adverse events were of mild or moderate severity ; the most frequently related adverse events were photosensitivity reaction , headache, nausea, and diarrhea. Conclusion: Sparfloxacin had an overall success rate of 91.5% for patients in this study and was generally well tolerated in the treatment of acute ba cterial maxillary sinusitis.