Maxillary Sinusitis
Conditions
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.
Interventions
DRUGlevofloxacin
levofloxacin 500 mg capsule by mouth qd x 10 days
Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
OTHERplacebo
placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sponsor assessment of clinical response for the Clinical per Protocol population | Test of Cure (TOC) visit (Day 17-24) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population | EOT visit and TOC visit |
| 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 |
| adverse events | Continuous |
Countries
Argentina, Chile, Costa Rica, Czechia, Estonia, Germany, India, Lithuania, Mexico, Poland, Russia, Slovakia, United States
Outcome results
None listed