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

Pfizer1 site541 target enrollmentJanuary 2003

ConditionsMaxillary Sinusitis

Interventionsplacebo levofloxacin

Drugsazithromycin SR (Zithromax; compound: CP-62,993)levofloxacin

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Maxillary Sinusitis
Sponsor: Pfizer
Enrollment: 541
Locations: 1
Primary Endpoint: sponsor assessment of clinical response for the Clinical per Protocol population
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

February 2004

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility 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.

Arms & Interventions

1

Intervention: placebo

2

Intervention: levofloxacin

2

Intervention: placebo

Outcomes

Primary Outcomes

sponsor assessment of clinical response for the Clinical per Protocol population

Time Frame: Test of Cure (TOC) visit (Day 17-24)

Secondary Outcomes

sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population(EOT visit and TOC visit)
investigator assessment of clinical response for the Clinical per Protocol population(TOC visit)
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population(TOC visit)
summary of baseline susceptibilities(Study endpoint)
adverse events(Continuous)
laboratory abnormalities(during and post-treatment)
sponsor assessment of clinical response for the Clinical per Protocol population(End of Treatment (EOT) visit (Day 11-13))
sponsor assessment of clinical response for the remaining study populations(EOT visit and TOC visit)