BAY12-8039: 5 Days for Sinusitis vs Placebo

Bayer

Status and phase

Completed

Phase 3

Conditions

Sinusitis

Treatments

Drug: Placebo

Drug: Moxifloxacin (Avelox, BAY12-8039)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00492024

11566

Details and patient eligibility

About

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.

Enrollment

374 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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