Community-based treatment of acute uncomplicated bacterial rhinosinusitis with gatifloxacin.
OBJECTIVE
We sought to evaluate gatifloxacin in adults with acute uncomplicated bacterial rhinosinusitis.


METHODS
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% beta-lactamase producers), Haemophilus influenzae (28% beta-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%).


CONCLUSIONS
Gatifloxacin is effective for patients with acute bacterial rhinosinusitis in the community.
Sher
Lawrence D
LD
Peninsula Research Associates, Rolling Hills Estates, CA 90274, USA. l.sher@verizon.net
Poole
Michael D
MD
Von Seggern
Kristen
K
Wikler
Matthew A
MA
Nicholson
Susan C
SC
Pankey
George A
GA
D000208:Acute Disease; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D017714:Community-Acquired Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D004351:Drug Resistance; D005260:Female; D024841:Fluoroquinolones; D005500:Follow-Up Studies; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D011358:Product Surveillance, Postmarketing; D012220:Rhinitis / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D012307:Risk Factors; D012852:Sinusitis / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D012907:Smoking / Q000009:adverse effects; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin