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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Birmingham, Alabama 35209, United States
Northport, Alabama 35476, United States
Jonesboro, Arkansas 72401, United States
Little Rock, Arkansas 72205, United States
Fresno, California 93720, United States
Fresno, California 93710, United States
Garden Grove, California 92840, United States
Orange, California 92868, United States
Roseville, California 95678, United States
San Diego, California 92106, United States
San Luis Obispo, California 93405, United States
Colorado Springs, Colorado 80909, United States
Bridgeport, Connecticut 06606, United States
Dunnellon, Florida 34432, United States
Hialeah, Florida 33013, United States
North Miami Beach, Florida 33179, United States
Pembroke Pines, Florida 33024, United States
Plantation, Florida 33324, United States
Atlanta, Georgia 30310, United States
Warner Robbins, Georgia 31093, United States
Warner Robins, Georgia 31088, United States
Louisville, Kentucky 40207, United States
Detroit, Michigan 48202, United States
Livonia, Michigan 48152, United States
Portage, Michigan 49024, United States
Butte, Montana 59701, United States
Elizabeth, New Jersey 07202-3672, United States
Lawrenceville, New Jersey 08698, United States
Somerville, New Jersey 08876, United States
Rochester, New York 14618, United States
Charlotte, North Carolina 28210, United States
Raleigh, North Carolina 27609, United States
Cincinnati, Ohio 45241, United States
Dayton, Ohio 45406, United States
Eugene, Oregon 97404, United States
Levittown, Pennsylvania 19056, United States
Norristown, Pennsylvania 19401, United States
Palmyra, Pennsylvania 17078, United States
Clarksville, Tennessee 37043, United States
Austin, Texas 78705, United States
College Station, Texas 77845, United States
El Paso, Texas 79904, United States
Houston, Texas 77074, United States
San Antonio, Texas 78229, United States
Salt Lake City, Utah 84109, United States
Salt Lake City, Utah 84121, United States
West Jordan, Utah 84084, United States
West Jordan, Utah 84088, United States
Tappahannock, Virginia 22560, United States
Bellingham, Washington 98225, United States
Greenfield, Wisconsin 53228, United States