BAY12-8039 5 Days Sinusitis vs Placebo

Condition(s) targeted: Respiratory Tract Infection; Bacterial Sinusitis

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

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Official title: Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg QD for 5 Days Versus Placebo in the Treatment of Acute Bacterial Sinusitis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The clinical response at the Test of Cure visit in the Modified ITT population

Secondary outcome: Time to clinical improvement of sinusitis symptoms; subject reported time to symptom improvement; time to return to normal activities, clinical response during therapy and long term follow up and safety

Detailed description: Number of arms: 2

(Placebo - 380 mg Microcrystalline Cellulose, Moxifloxacin - 400 mg)

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

Criteria:

Inclusion Criteria:

- 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:

A. 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

B. 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

Exclusion Criteria:

- 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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Capstone Clinical Trials, Inc., Birmingham, Alabama 35205, United States; Recruiting
Rita Aderholt, Phone: 205-877-2766, Email: capstoneclin@aol.com

West Alabama Research, Inc., Northport, Alabama 35476, United States; Completed

Office of Dr. Marc H. Routman, MD, Birmingham, Alabama 35209, United States; Recruiting
Lydia Cozad, LPN, Phone: 205-314-3432, Email: capstoneclin@aol.com

NEA Clinic, Jonesboro, Arkansas 72401, United States; Recruiting
Leigh Ann Reed, Phone: 870-934-5578, Email: lreed@researchsolutionscorp.com

Teton Research, LLC, Little Rock, Arkansas 72205, United States; Not yet recruiting
Angie Allred, Phone: 501-975-8989

Children's Hospital of Orange County, Orange, California 92868-3974, United States; Active, not recruiting

Clinical Research Center of California, San Diego, California 92106, United States; Completed

Community Medical Providers, Clovis, California 93611, United States; Recruiting
Joanne Crawford, Phone: 559-299-2224

SARC Research Center, Fresno, California 93720, United States; Recruiting
Aman S. Gill, MD, Phone: 559-447-2237

Digestive and Liver Disease Specialists, Garden Grove, California 92840, United States; Completed

Coastal Medical Research Group, Inc., San Luis Obispo, California 93401, United States; Recruiting
Brooks Holley, Phone: 805-549-7570

Allergy Medical Group of the North Area, Roseville, California 95678, United States; Not yet recruiting
Brenda Cobb, Phone: 916-782-7758, Email: brenda@allergymedgroup.com

Colorado Otolaryngology Associates, Colorado Springs, Colorado 80909, United States; Recruiting
Sharon Woodworth, RN, Phone: 719-867-7800, Email: swoodworth@coaentdocs.com

Connecticut Sinus Center, Bridgeport, Connecticut 06606, United States; Recruiting
Leticia Belton, Phone: 203-372-0009

Eastern Research, Hialeah, Florida 33013, United States; Recruiting
Raquel Gonzalez, Phone: 305-681-3111, Email: easternresearch2@aol.com

Internal Medicine Associates of South Florida, North Miami Beach, Florida 33179, United States; Recruiting
Judy E. Magnum, Phone: 305-940-6973, Email: judymagnum@aol.com

Southeastern Ear, Nose, Throat Sinus Center, Pembroke Pines, Florida 33024, United States; Not yet recruiting
Judy E. Magnum, Phone: 954-437-5333, Email: judymagnum@aol.com

Broward Head, Neck, and Facial Plastic Surgery, Plantation, Florida 33324, United States; Recruiting
Sheila L. Guilder, Phone: 954-474-0243, Email: shesteg@aol.com

Bellam Medical Clinic, Dunnellon, Florida 34432, United States; Not yet recruiting
Bayer Clinical Trials Contact, Phone: 352-465-1199

Clinical Research Center of Georgia, Inc., Warner Robins, Georgia 31088, United States; Completed

Clinical Research Solutions, Inc., Atlanta, Georgia 30310, United States; Completed

Commonwealth Ear, Nose & Throat, Louisville, Kentucky 40207, United States; Recruiting
Diana Godwin, Phone: 502-893-0159

Michigan Institute of Medicine, Livonia, Michigan 48152, United States; Active, not recruiting

ProMed Physicians, Portage, Michigan 49024, United States; Completed

Henry Ford Health System, Detroit, Michigan 48202, United States; Not yet recruiting
Tiffany Pearce, Phone: 313-916-1856, Email: tpearce1@hfhs.org

Mercury Street Medical, Butte, Montana 59701, United States; Not yet recruiting
Bayer Clinical Trials Contact, Phone: 406-723-1300

Central Jersey Health Care Associates, LLC, Elizabeth, New Jersey 07202-3672, United States; Recruiting
Patricia Rodrigues, Phone: 908-354-5353, Email: patriciarodrigues7@hotmail.com

ENT Care, Somerville, New Jersey 08876, United States; Recruiting
Monika Tiemeyer, Phone: 908-704-9696, Email: monika.tiemeyer@pharmatrials.info

Office of Dr. Chetan Shah, MD, Lawrenceville, New Jersey 08698, United States; Not yet recruiting
Michael Young, Phone: 609-895-6655, Email: mike.young@pharmatrials.info

Office of Dr. Chetan Shah, MD, Lawrenceville, New Jersey 08698, United States; Not yet recruiting
James Paidas, Phone: 609-895-6655

University Otolaryngology Associates, Rochester, New York 14618, United States; Recruiting
Donna Rekkerth, FNP, Phone: 585-758-5700, Email: donna_rekkerth@urmc.rochester.edu

North Carolina Arthritis & Allergy Care Center, PA, Raleigh, North Carolina 27609, United States; Completed

New Horizon Clinical Research, Cincinnati, Ohio 45241, United States; Recruiting
Wayne Shupp, Phone: 513-769-2767, Email: wshupp@nher.com

Dayton Clinical Research, Dayton, Ohio 45406, United States; Recruiting
Fran Angerer, PA-C, Phone: 937-276-4311, Email: daytonclinical@aol.com

Williamette Valley Clinical Studies, Eugene, Oregon 97404, United States; Recruiting
Brady vanCleave, Phone: 541-461-0132, Email: swanpar@aol.com

Pearl Clinical Research, Norristown, Pennsylvania 19401, United States; Recruiting
Suzanne Bolger, Phone: 610-270-9571, Email: pearlresearch@aol.com

Associated Otolaryngologists of Pennsylvania, Palmyra, Pennsylvania 17078, United States; Not yet recruiting
Sidone M. Keener, RN, Phone: 717-832-0500

Family Medical Associates, Levittown, Pennsylvania 19056, United States; Recruiting
Lin Denton, RN, Phone: 215-269-7231, Email: fox_research@verizon.net

Alpha Clinical Research, LLC, Clarksville, Tennessee 37043, United States; Active, not recruiting

Pharmaceutical C-Trials, Inc., Houston, Texas 77074, United States; Completed

San Antonio Ear, Nose & Throat Research, San Antonio, Texas 78229, United States; Recruiting
Peggy Smith, Phone: 210-558-7029

Corona Research Consultants, Inc., El Paso, Texas 79904, United States; Completed

J & S Studies, Inc., Bryan, Texas 77802, United States; Not yet recruiting
Bayer Clinical Trials Contact, Phone: 979-774-5933

J. Lewis Research, Inc., Salt Lake City, Utah 84109, United States; Recruiting
Susanne Johnson, Phone: 801-487-2072

J. Lewis Research, Inc., Salt Lake City, Utah 84121, United States; Recruiting
Janice Walker, RN, Phone: 801-365-1032, Email: jwalker@earthlink.net

J. Lewis Research, Inc., West Jordan, Utah 84088, United States; Recruiting
Sean Hansen, RN, Phone: 801-352-7106

J. Lewis Research, Inc., West Jordan, Utah 84084, United States; Completed

Rappahannock Research Center, Tappahannock, Virginia 22560, United States; Completed

Bellingham Asthma, Allergy & Immunology Clinic, Bellingham, Washington 98225, United States; Active, not recruiting

Allergy, Asthma & Sinus Center, SC, Greenfield, Wisconsin 53228, United States; Recruiting
Jodie Nelson, Phone: 414-529-8500

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Starting date: January 2005
Last updated: August 20, 2007