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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643409

Purpose

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 III

MedlinePlus related topics: Sinusitis

Drug Information available for: Azithromycin Levofloxacin Ofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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:	504
Study Start Date:	January 2003
Study Completion Date:	February 2004

Arms	Assigned Interventions
1: Experimental	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
2: Experimental	Drug: levofloxacin levofloxacin 500 mg capsule by mouth qd x 10 days Other: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 sinusitus, 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

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

Show 93 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661078
Study First Received:	March 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00643409
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Azithromycin

Ofloxacin
Maxillary Sinusitis
Sinusitis

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Diseases
Therapeutic Uses
Anti-Infective Agents, Urinary

Enzyme Inhibitors
Renal Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009