Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox (SPEED)

• Patient-reported symptom improvement using SNOT-16 questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ] [ Designated as safety issue: No ]
• Clinical Response [ Time Frame: End of Treatment ] [ Designated as safety issue: Yes ]
• Bacteriological Response [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
• Activity Impairment Assessment questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ] [ Designated as safety issue: No ]
• Incidence of Premature Termination [ Time Frame: Premature Termination ] [ Designated as safety issue: Yes ]
• Adverse Events Collection [ Time Frame: Up to End of Treatment (Day 10-13) ] [ Designated as safety issue: Yes ]

• Patient-reported symptom improvement using SNOT-16 questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ] [ Designated as safety issue: No ]
• Clinical Response [ Time Frame: End of Treatment ] [ Designated as safety issue: Yes ]
• Bacteriological Response [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
• Activity Impairment Assessment questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ] [ Designated as safety issue: No ]
• Incidence of Premature Termination [ Time Frame: Premature Termination ] [ Designated as safety issue: Yes ]
• Adverse Events [ Time Frame: Up to End of Treatment (Day 10-13) ] [ Designated as safety issue: Yes ]

Inclusion Criteria:

• Clinical diagnosis of acute sinusitis with signs and symptoms present for >7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:a. The presence of 1 or more of the following on a radiographic paranasal sinus film (Waters' view) or limited CT scan:** evidence of air-fluid levels** opacification. 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 moderate or severe facial pain or malar tenderness** Minor Symptoms*** Cough or frequent throat clearing*** Frontal headache*** Halitosis*** Fever (oral > 38.0°C/100.4°F, tympanic > 38.5°C/101.2°F)*** Purulent secretions obtained via middle meatus secretion sampling using nasal endoscopic technique; the specimen sent for Gram stain, 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 (patients with history of sinus surgery may be included; patients with recurrent sinusitis may be included)
• Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses- Received systemic antibacterial therapy likely to be effective in sinusitis for more than 24 hours within 7 days of enrollment- A requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol- Known immunodeficiency diseases including AIDS (CD4 <200)- On topical nasal or systemic corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment- History of allergy to quinolone antibiotics or related compounds- Pregnant or breast feeding- Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
• Received an investigational drug in the past 30 days- Unable to take oral medication- Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
• End stage liver cirrhosis (class Child-Pugh C)- Severe renal impairment requiring dialysis
• Previous history of tendinopathy associated with quinolones- Any symptoms that suggest that the patient's current illness is allergic rhinitis (e.g., repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
• Diagnosis of rapidly fatal illness with a life expectance of less than 6 months- Previously enrolled in this clinical study- Uncorrected hypokalaemia