OPEN-LABEL ASSESSMENT OF LEVOFLOXACIN FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS IN ADULTS

Purpose: To evaluate the efficacy and safety of levofloxacin (500 mg o rally once daily for 10 to 14 days) in treating adult outpatients with acute bacterial sinusitis. Patients and Methods: A total of 329 patie nts enrolled in the study at 24 centers. All patients had a pre-therap y Gram's stain and culture of sinus exudate obtained by antral punctur e or nasal endoscopy. Clinical response was assessed on the basis of s igns and symptoms and sinus radiograph or computed tomography results. Microbiologic cure rates were determined on the basis of presumed plu s documented eradication of the pre-therapy pathogen(s). Results: The most common pathogens were Haemophilus influenzae, Streptococcus pneum oniae, Staphylococcus aureus, and Moraxella catarrhalis. Of 300 clinic ally evaluable patients, 175 (58%) were cured and 90 (30%) were improv ed at the post-therapy evaluation, resulting in a clinical success rat e of 88%. Thirty-five patients (12%) clinically failed treatment. The microbiologic eradication rate (presumed plus documented) among 138 mi crobiologically evaluable patients was 92%. Microbiologic eradication rates (presumed plus documented) of the most common pathogens ranged f rom 93% (M. catarrhalis) to 100% (S. pneumoniae) at the post-therapy v isit. All but one of the 265 patients who were cured or improved at po st-therapy returned for a long-term follow-up visit; 243 (92%) remaine d well 4 to 6 weeks after therapy; and 21 (8%) had a relapse of sympto ms. Adverse events considered to be related to levofloxacin administra tion were reported by 29 patients (9%). The most common drug-related a dverse events were diarrhea, flatulence, and nausea; most adverse even ts were mild to moderate in severity. Conclusion: The results of this study indicate that levofloxacin 500 mg once daily is an effective and safe treatment for acute bacterial sinusitis.