Clinical experience with moxifloxacin in patients with respiratory tract infections.
BACKGROUND
Moxifloxacin is an advanced-generation fluoroquinolone used primarily for the treatment of respiratory tract infections.


OBJECTIVE
To further investigate moxifloxacin's general and cardiac safety and evaluate its efficacy in the community practice setting in a large surveillance study.


METHODS
A total of 18,409 outpatients with suspected bacterial episodes of acute sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia of mild to moderate severity were enrolled at 3377 community practice sites. Patients with sinusitis or pneumonia received once-daily oral moxifloxacin 400 mg for 10 days; those with bronchitis received 5 days' treatment. At follow-up, within 48 hours after the end of treatment, adverse event information was collected. An external safety committee assessed possible cardiac-related events. Efficacy was also evaluated at follow-up via the degree of resolution of clinical signs and symptoms.


RESULTS
Of 18,374 safety-valid patients, 17.7% experienced adverse events and 14.3% experienced drug-related adverse events. The most common drug-related adverse events were nausea (5.3%), diarrhea (2.2%), and dizziness (2.0%). There was no clinical evidence of increased risk of cardiac arrhythmias with moxifloxacin treatment. Of 17,137 patients included in the efficacy analysis, 92.9% overall experienced clinical cure or improvement (92.8% with sinusitis, 92.9% with bronchitis, 94.1% with pneumonia).


CONCLUSIONS
Once-daily oral moxifloxacin 400 mg was shown to be safe and effective in this trial for the treatment of respiratory tract infections of suspected bacterial origin in the clinical practice setting.
Faich
Gerald A
GA
Pharmaceutical Safety Assessments, Inc., Narberth, PA 19072-2156, USA. gfaich@yahoo.com
Morganroth
Joel
J
Whitehouse
Alan B
AB
Brar
Jugroop S
JS
Arcuri
Peter
P
Kowalsky
Steven F
SF
Haverstock
Daniel C
DC
Celesk
Roger A
RA
Church
Deborah A
DA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001372:Aza Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D012141:Respiratory Tract Infections / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000077266:Moxifloxacin