Official Title: “Prospective, Multicenter, Open, Uncontrolled Trial to Evaluate the Time to Bacterial Eradication and Key Symptom Relief in the Treatment of Acute Bacterial Maxillary Sinusitis With Moxifloxacin 400 mg QD”

This study evaluated the time to eliminate the infecting bacteria and time to resolution of key clinical symptoms of acute bacterial sinusitis

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.

Intervention(s) in this Clinical Trial

• Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Moxifloxacin 400 mg once orally daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a

Primary Measures

• Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae
  • Time Frame: Days 1, 2, 3 of treatment
    Safety Issue?: No

Secondary Measures

• Patient-reported symptom improvement using SNOT-16 questionnaire
  • Time Frame: Up to End of Treatment (Day 10-13)
    Safety Issue?: No
• Clinical Response
  • Time Frame: End of Treatment
    Safety Issue?: Yes
• Bacteriological Response
  • Time Frame: End of Treatment
    Safety Issue?: No
• Activity Impairment Assessment questionnaire
  • Time Frame: Up to End of Treatment (Day 10-13)
    Safety Issue?: No
• Incidence of Premature Termination
  • Time Frame: Premature Termination
    Safety Issue?: Yes
• Adverse Events
  • Time Frame: Up to End of Treatment (Day 10-13)
    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:
• 1. 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
• 2. 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668304

Study ID Number: 100569

ClinicalTrials.gov Identifier: NCT00668304

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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