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

NCT ID: NCT00668304

Last Updated: 2014-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-01-31

Brief Summary

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.

Conditions

Maxillary Sinusitis

Keywords

Sinusitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type: DRUG

Moxifloxacin 400 mg once orally daily

Interventions

Avelox (Moxifloxacin, BAY12-8039)

Moxifloxacin 400 mg once orally daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Birmingham, Alabama, United States

Hoover, Alabama, United States

Jonesboro, Arkansas, United States

Searcy, Arkansas, United States

Fresno, California, United States

Riverside, California, United States

San Francisco, California, United States

Colorado Springs, Colorado, United States

Longmont, Colorado, United States

Bridgeport, Connecticut, United States

DeLand, Florida, United States

Shreveport, Louisiana, United States

Detroit, Michigan, United States

North Massapequa, New York, United States

Rochester, New York, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Yukon, Oklahoma, United States

Lake Oswego, Oregon, United States

Harrisburg, Pennsylvania, United States

Greenville, South Carolina, United States

Orangeburg, South Carolina, United States

Jackson, Tennessee, United States

Carrollton, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Richmond, Virginia, United States

Winchester, Virginia, United States

Spokane, Washington, United States

San Juan Bautista, Buenos Aires, Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Córdoba, Córdoba Province, Argentina

Rosario, Santa Fe Province, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Countries

United States; Argentina

Other Identifiers

100569

Identifier Type: -

Identifier Source: org_study_id