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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643409
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : May 11, 2011
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Maxillary Sinusitis Drug: azithromycin SR (Zithromax; compound: CP-62,993) Other: placebo Drug: levofloxacin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2003
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arms and Interventions
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Arm Intervention/treatment
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
placebo
Experimental: 2 Drug: levofloxacin
levofloxacin 500 mg capsule by mouth qd x 10 days

Other: placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 17-24) ]

Secondary Outcome Measures :
  1. sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population [ Time Frame: EOT visit and TOC visit ]
  2. investigator assessment of clinical response for the Clinical per Protocol population [ Time Frame: TOC visit ]
  3. bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ]
  4. summary of baseline susceptibilities [ Time Frame: Study endpoint ]
  5. adverse events [ Time Frame: Continuous ]
  6. laboratory abnormalities [ Time Frame: during and post-treatment ]
  7. sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: End of Treatment (EOT) visit (Day 11-13) ]
  8. sponsor assessment of clinical response for the remaining study populations [ Time Frame: EOT visit and TOC visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643409


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

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643409    
Other Study ID Numbers: A0661078
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Sinusitis
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Azithromycin
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
 Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors