QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Résumé Extracto Full Text PDF Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Articles Ahead of Print [Order Reprint] Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Faich, G. A Articles by Church, D. A Search for Related Content PubMed PubMed Citation Articles by Faich, G. A Articles by Church, D. A

INFECTIOUS DISEASES

Clinical Experience with Moxifloxacin in Patients with Respiratory Tract Infections

President, Pharmaceutical Safety Assessments, Inc., Narberth, PA

Joel Morganroth, MD

Clinical Professor of Medicine, School of Medicine, University of Pennsylvania, Philadelphia, PA; Chief Scientist, eResearch Technology, Inc., Philadelphia

Alan B Whitehouse, MD

Otolaryngologist, Augusta ENT, University Hospital, Augusta, GA; Assistant Clinical Professor,Medical College of Georgia, Augusta

Jugroop S Brar, MD

Staff Physician, Saratoga Emergency Physicians, Saratoga Springs, NY

Peter Arcuri, DO

Family Practitioner, Philadelphia

Steven F Kowalsky, PharmD

Global Medical Director, Global Clinical Development, Bayer Pharmaceuticals Corporation, West Haven, CT

Daniel C Haverstock, MS

Deputy Director Statistics, Global Biometry, Bayer Pharmaceuticals Corporation

Roger A Celesk, PhD

Deputy Director Drug Safety, Drug Safety Assurance, Bayer Pharmaceuticals Corporation

Deborah A Church, MD

Director, Medical Sciences, Anti-Infectives, Bayer Pharmaceuticals Corporation

Reprints: Gerald A Faich MD MPH, Pharmaceutical Safety Assessments, Inc., 104 Foxhall Ln., Narberth, PA 19072-2156, fax 610/664-1148, gfaich{at}yahoo.com

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.

Key Words: bronchitis, moxifloxacin, pneumonia, safety, sinusitis

Published Online, March 16, 2004. www.theannals.com, DOI 10.1345/aph.1C066

This article has been cited by other articles:

				M. Martin, S. Quilici, T. File, J. Garau, A. Kureishi, and M. Kubin Cost-effectiveness of empirical prescribing of antimicrobials in community-acquired pneumonia in three countries in the presence of resistance J. Antimicrob. Chemother., May 1, 2007; 59(5): 977 - 989. [Abstract] [Full Text] [PDF]