Clinical trial NCT00643409: A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Maxillary Sinusitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: sponsor assessment of clinical response for the Clinical per Protocol population
timeFrame: Test of Cure (TOC) visit (Day 17-24)
Secondary outcomes:
measure: sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population
timeFrame: EOT visit and TOC visit
measure: investigator assessment of clinical response for the Clinical per Protocol population
timeFrame: TOC visit
measure: bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
timeFrame: TOC visit
measure: summary of baseline susceptibilities
timeFrame: Study endpoint
measure: adverse events
timeFrame: Continuous
measure: laboratory abnormalities
timeFrame: during and post-treatment
measure: sponsor assessment of clinical response for the Clinical per Protocol population
timeFrame: End of Treatment (EOT) visit (Day 11-13)
measure: sponsor assessment of clinical response for the remaining study populations
timeFrame: EOT visit and TOC visit
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Hueytown
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Pelham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Clovis
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Bridgeport
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Portage
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Richland
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Three Rivers
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Missoula
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Missoula
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Charlote
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Morrisville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Orangeburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Amarillo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Amarillo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bryan
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Murray
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Bo. Aranjuez
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Escazu
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Guadalupe
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: La Uruca
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Prague 10
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Rostock
country: Germany
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Bielsko-Biala
country: Poland
facility: Pfizer Investigational Site
city: Katowice
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: