Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
374 participants
INTERVENTIONAL
2005-01-31
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Moxifloxacin 400 mg
Moxifloxacin 400mg once daily for 5 days
Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin - 400 mg once a day for 5 days
Placebo
Matching placebo for 5 days
Placebo
Placebo - 380 mg Microcrystalline Cellulose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Moxifloxacin (Avelox, BAY12-8039)
Moxifloxacin - 400 mg once a day for 5 days
Placebo
Placebo - 380 mg Microcrystalline Cellulose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Northport, Alabama, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Fresno, California, United States
Fresno, California, United States
Garden Grove, California, United States
Orange, California, United States
Roseville, California, United States
San Diego, California, United States
San Luis Obispo, California, United States
Colorado Springs, Colorado, United States
Bridgeport, Connecticut, United States
Dunnellon, Florida, United States
Hialeah, Florida, United States
North Miami Beach, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Atlanta, Georgia, United States
Warner Robbins, Georgia, United States
Warner Robins, Georgia, United States
Louisville, Kentucky, United States
Detroit, Michigan, United States
Livonia, Michigan, United States
Portage, Michigan, United States
Butte, Montana, United States
Elizabeth, New Jersey, United States
Lawrenceville, New Jersey, United States
Somerville, New Jersey, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Eugene, Oregon, United States
Levittown, Pennsylvania, United States
Norristown, Pennsylvania, United States
Palmyra, Pennsylvania, United States
Clarksville, Tennessee, United States
Austin, Texas, United States
College Station, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
West Jordan, Utah, United States
Tappahannock, Virginia, United States
Bellingham, Washington, United States
Greenfield, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11566
Identifier Type: -
Identifier Source: org_study_id