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Antimicrobial Agents and Chemotherapy, September 2003, p. 2770-2774, Vol. 47, No. 9
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.9.2770-2774.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Randomized Double-Blind Study Comparing 3- and 6-Day Regimens of Azithromycin with a 10-Day Amoxicillin-Clavulanate Regimen for Treatment of Acute Bacterial Sinusitis

Dan C. Henry,1 Ernie Riffer,2 William N. Sokol,3 Naumann I. Chaudry,4 and Robert N. Swanson4*

Foothill Family Clinic, Salt Lake City, Utah,1 Central Phoenix Medical Center, Phoenix, Arizona,2 Health Research Institute, Newport Beach, California,3 Pfizer Inc, New York, New York4

Received 25 November 2002/ Returned for modification 14 February 2003/ Accepted 11 April 2003

A randomized, double-blind, multicenter study of adults with acute bacterial sinusitis (ABS) compared the efficacy and safety of two azithromycin (AZM) regimens, 500 mg/day once daily for 3 days (AZM-3) or 6 days (AZM-6) to the efficacy and safety of an amoxicillin-clavulanate (AMC) regimen of 500-125 mg three times daily for 10 days. A total of 936 subjects with clinically and radiologically documented ABS were treated (AZM-3, 312; AZM-6, 311; AMC, 313). Clinical success rates were equivalent among per-protocol subjects at the end of therapy (AZM-3, 88.8%; AZM-6, 89.3%; AMC, 84.9%) and at the end of the study (AZM-3, 71.7%; AZM-6, 73.4%; AMC, 71.3%). Subjects treated with AMC reported a higher incidence of treatment-related adverse events (AE) (51.1%) than AZM-3 (31.1%, P < 0.001) or AZM-6 (37.6%, P < 0.001). More AMC subjects discontinued the study (n = 28) than AZM-3 (n = 7) and AZM-6 (n = 11) subjects. Diarrhea was the most frequent treatment-related AE. AZM-3 and AZM-6 were each equivalent in efficacy and better tolerated than AMC for ABS.

* Corresponding author. Mailing address: Pfizer Inc, 235 East 42nd St., New York, NY 10017-5755. Phone: (212) 573-2975. Fax: (212) 808-6341. E-mail: Swansr1{at}pfizer.com.

Antimicrobial Agents and Chemotherapy, September 2003, p. 2770-2774, Vol. 47, No. 9
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.9.2770-2774.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Masood, A., Moumoulidis, I., Panesar, J. (2007). Acute rhinosinusitis in adults: an update on current management. Postgrad. Med. J. 83: 402-408 [Abstract] [Full Text]  
  • D'Ignazio, J., Camere, M. A., Lewis, D. E., Jorgensen, D., Breen, J. D. (2005). Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults. Antimicrob. Agents Chemother. 49: 4035-4041 [Abstract] [Full Text]  
  • Piccirillo, J. F. (2004). Acute Bacterial Sinusitis. NEJM 351: 902-910 [Full Text]  


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