A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 19, 2008
Last updated: May 10, 2011
Last verified: May 2011
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.

Condition Intervention Phase
Maxillary Sinusitis
Drug: azithromycin SR (Zithromax; compound: CP-62,993)
Other: placebo
Drug: levofloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 17-24) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population [ Time Frame: EOT visit and TOC visit ] [ Designated as safety issue: No ]
  • investigator assessment of clinical response for the Clinical per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • laboratory abnormalities [ Time Frame: during and post-treatment ] [ Designated as safety issue: Yes ]
  • sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: End of Treatment (EOT) visit (Day 11-13) ] [ Designated as safety issue: No ]
  • sponsor assessment of clinical response for the remaining study populations [ Time Frame: EOT visit and TOC visit ] [ Designated as safety issue: No ]

Enrollment: 541
Study Start Date: January 2003
Study Completion Date: February 2004
Arms Assigned Interventions
Experimental: 1 Drug: azithromycin SR (Zithromax; compound: CP-62,993)
Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
Other: placebo
Experimental: 2 Drug: levofloxacin
levofloxacin 500 mg capsule by mouth qd x 10 days
Other: placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.

Exclusion Criteria:

Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00643409

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Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643409     History of Changes
Other Study ID Numbers: A0661078 
Study First Received: March 19, 2008
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Maxillary Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2016