BAY12-8039: 5 Days for Sinusitis vs Placebo

Completed · Phase 3 · Has a placebo group

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT00492024

Run by

Bayer

People needed

374

Starts

2005-01-01

Expected to finish

2008-03-01

Last updated by the study team

2013-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Northport, Alabama, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Fresno, California, United States
• Study site — Fresno, California, United States
• Study site — Garden Grove, California, United States
• Study site — Orange, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Dunnellon, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Warner Robbins, Georgia, United States
• Study site — Warner Robins, Georgia, United States
• Study site — Louisville, Kentucky, United States
• Study site — Detroit, Michigan, United States
• Study site — Livonia, Michigan, United States
• Study site — Portage, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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