Community-based treatment of acute uncomplicated bacterial rhinosinusitis with gatifloxacin

• Published in: Otolaryngology-head and neck surgery 2002-09, Vol.127 (3), p.182-189
• Main Authors: Sher, Lawrence D., Poole, Michael D., Von Seggern, Kristen, Wikler, Matthew A., Nicholson, Susan C., Pankey, George A.
• Format: Article
• Language: English
• Subjects: Acute Disease; Aged; Anti-Infective Agents - therapeutic use; Bacterial Infections - diagnosis; Bacterial Infections - drug therapy; Bacterial Infections - microbiology; Community-Acquired Infections - diagnosis; Community-Acquired Infections - drug therapy; Community-Acquired Infections - microbiology; Drug Resistance; Female; Fluoroquinolones; Follow-Up Studies; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Pneumonia, Bacterial - diagnosis; Pneumonia, Bacterial - drug therapy; Pneumonia, Bacterial - microbiology; Product Surveillance, Postmarketing; Rhinitis - diagnosis; Rhinitis - drug therapy; Rhinitis - microbiology; Risk Factors; Sinusitis - diagnosis; Sinusitis - drug therapy; Sinusitis - microbiology; Smoking - adverse effects; Tomography, X-Ray Computed; Treatment Outcome
• ISSN: 0194-5998; 1097-6817
• DOI: 10.1067/mhn.2002.127590

Objective: We sought to evaluate gatifloxacin in adults with acute uncomplicated bacterial rhinosinusitis. Study Design: TeqCES was an open-label, multicenter, noncomparative study of the safety and efficacy of gatifloxacin. More than 11,000 adult patients with acute uncomplicated rhinosinusitis received gatifloxacin 400 mg once daily for 10 days. Results: Moraxella catarrhalis (91% β-lactamase producers), Haemophilus influenzae (28% β-lactamase producers), Streptococcus pneumoniae (18% intermediately resistant and 14% fully resistant to penicillin), and Staphylococcus aureus were the predominant pathogens isolated from purulent nasal discharge. More than 99% of rhinosinusitis pathogens isolated from the nasopharynx of patients meeting the clinical criteria for rhinosinusitis were susceptible to gatifloxacin. Among 10,353 patients whose clinical response could be determined, 91.6% were cured. Clinical cure rates exceeded 90% for the major pathogens. Gatifloxacin was well tolerated; drug-related adverse events that occurred in 1% or more of patients were nausea (4.4%), dizziness (1.8%), diarrhea (1.4%), and headache (1.0%). Conclusion: Gatifloxacin is effective for patients with acute bacterial rhinosinusitis in the community. (Otolaryngol Head Neck Surg 2002;127:182-89.)