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

Condition(s) targeted: Maxillary Sinusitis

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

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

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

Primary outcome: Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae

Secondary outcome:

Patient-reported symptom improvement using SNOT-16 questionnaire

Clinical Response

Bacteriological Response

Activity Impairment Assessment questionnaire

Incidence of Premature Termination

Adverse Events

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

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

Buenos Aires 1416, Argentina

Buenos Aires C1280AEB, Argentina

Cordoba 5000, Argentina

Birmingham, Alabama 35206, United States

Hoover, Alabama 35216-5453, United States

Searcy, Arkansas 72143, United States

Jonesboro, Arkansas 72401, United States

Florecio Varela, Buenos Aires 1888, Argentina

Fresno, California 93720, United States

Riverside, California 92506, United States

Longmont, Colorado 80501, United States

Colorado Springs, Colorado 80909, United States

Bridgeport, Connecticut 06606, United States

DeLand, Florida 32720-2560, United States

Shreveport, Louisiana 71105, United States

North Massapequa, New York 11758, United States

Columbus, Ohio 43235, United States

Yukon, Oklahoma 73099, United States

Oklahoma City, Oklahoma 73120, United States

Lake Oswego, Oregon 97035, United States

Harrisburg, Pennsylvania 17110, United States

Rosario, Santa Fé 2000, Argentina

Greenville, South Carolina 29607, United States

Orangeburg, South Carolina 29118, United States

Jackson, Tennessee 38301, United States

Carrollton, Texas 75010, United States

San Miguel de Tucumán, Tucumán 4000, Argentina

Salt Lake City, Utah 84102, United States

Richmond, Virginia 23229, United States

Charlottesville, Virginia 22902, United States

Winchester, Virginia 22601, United States

Spokane, Washington 99202-1334, United States

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Starting date: June 2004
Ending date: January 2005
Last updated: May 21, 2008