BAY12-8039: 5 Days for Sinusitis vs Placebo
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: Moxifloxacin (Avelox, BAY12-8039); Placebo
Intervention description: Moxifloxacin - 400 mg once a day for 5 days; Placebo - 380 mg Microcrystalline Cellulose
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 374.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Respiratory Tract Infection; Bacterial Sinusitis

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