[Levofloxacin in the treatment of acute and bacteriologically documented sinusitis with high risk of complications]. / Efficacité et tolérance de la lévofloxacine dans le traitement des sinusites aiguës bactériologiquement documentées et à risque de complications.

ABSTRACT

OBJECTIVES: The authors had for aim to evaluate the efficacy and tolerance of oral levofloxacin (500 mg once a day during ten days), as a treatment for acute bacterial sinusitis at risk for complications in adult patients. PATIENTS AND METHODS: This was a prospective, multicenter, open, non-comparative, efficacy and tolerance study of levofloxacin in acute sinusitis at risk for complications, radiologically confirmed, and with documentation of the bacterial origin by fiberoptic rhinoscopy. RESULTS: Two hundred and thirty-one patients were included and 174 patients had an X ray confirmed sinusitis. The localization was frontal in 81% patients, sphenoidal in 9.2%, ethmoidosphenoidal in 2.3%, and 7.5% patients had a pansinusitis. One hundred and thirty-three patients had a probable or proven bacterial infection, involving Streptococcus pneumoniae (26.0%), enterobacteriaceae (19.7%), Haemophilus influenzae (17.3%), Staphylococcus aureus (15.0%), streptococci other than S. pneumoniae (7.9%), and Branhamella catarrhalis (5.5%). One hundred and one patients constituted the per protocol population. Clinical success was observed in 94.1 % patients (95/101), and 85.1% (86/101), respectively 7 to 14 days and three to four weeks after the end of treatment, with consistent success rates according to the localization of the infection, and the various pathogens involved. The tolerance data was as expected for levofloxacin. CONCLUSIONS: The results of this study show that levofloxacin, (one 500 mg tablet QD during ten days) is efficient in over 94% patients with bacteriologically documented sinusitis at risk for complications.