Clinical trial NCT00492024: BAY12-8039: 5 Days for Sinusitis vs Placebo
Official title: Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sinusitis
Keywords: Respiratory Tract Infection
Bacterial Sinusitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 374
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 purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all the following criteria at the time of enrollment:

* Age \>/= 18 years
* Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but \< 28 days as defined by A), radiographic, and B) clinical criteria, as follows:

  * Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification
  * Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:

    * Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness
    * Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy

Exclusion Criteria:

Subjects with one or more of the following criteria will not be eligible for this study:

* History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)
* History of sinus surgery (antral sinus puncture is not considered as a surgery)
* Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
* Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses

Primary outcomes:
measure: Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))
timeFrame: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment
Secondary outcomes:
measure: Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach
timeFrame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
measure: Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach
timeFrame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)
measure: Percentage of Subjects With Clinical Improvement During Therapy
timeFrame: Day 3 of treatment
measure: Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up
timeFrame: Day 12 to 26 after end of treatment
Other outcomes:
measure: Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))
timeFrame: At 'Test-of-Cure', Day 1-5 after end of treatment
Locations:
city: Birmingham
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: Fresno
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Orange
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Dunnellon
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Warner Robbins
country: United States
state: Georgia
city: Warner Robins
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Detroit
country: United States
state: Michigan
city: Livonia
country: United States
state: Michigan
city: Portage
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Elizabeth
country: United States
state: New Jersey
city: Lawrenceville
country: United States
state: New Jersey
city: Somerville
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Levittown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Palmyra
country: United States
state: Pennsylvania
city: Clarksville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Tappahannock
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Greenfield
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Hadley JA, Mosges R, Desrosiers M, Haverstock D, van Veenhuyzen D, Herman-Gnjidic Z. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010 May;120(5):1057-62. doi: 10.1002/lary.20878.