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

• ClinicalTrials.gov Identifier: NCT00668304
• Recruitment Status: Completed
• First Posted: April 29, 2008
• Last Update Posted: December 19, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Maxillary Sinusitis	Drug: Avelox (Moxifloxacin, BAY12-8039)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 192 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2004
• Actual Study Completion Date: January 2005

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1	Drug: Avelox (Moxifloxacin, BAY12-8039); Moxifloxacin 400 mg once orally daily

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Patient-reported symptom improvement using SNOT-16 questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
2. Clinical Response [ Time Frame: End of Treatment ]
3. Bacteriological Response [ Time Frame: End of Treatment ]
4. Activity Impairment Assessment questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
5. Incidence of Premature Termination [ Time Frame: Premature Termination ]
6. Adverse Events Collection [ Time Frame: Up to End of Treatment (Day 10-13) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35206

Hoover, Alabama, United States, 35216-5453

United States, Arkansas

Jonesboro, Arkansas, United States, 72401

Searcy, Arkansas, United States, 72143

United States, California

Fresno, California, United States, 93720

Riverside, California, United States, 92506

San Francisco, California, United States, 94102

United States, Colorado

Colorado Springs, Colorado, United States, 80909

Longmont, Colorado, United States, 80501

United States, Connecticut

Bridgeport, Connecticut, United States, 06606

United States, Florida

DeLand, Florida, United States, 32720-2560

United States, Louisiana

Shreveport, Louisiana, United States, 71105

United States, Michigan

Detroit, Michigan, United States, 48202

United States, New York

North Massapequa, New York, United States, 11758

Rochester, New York, United States, 14618

United States, Ohio

Columbus, Ohio, United States, 43235

United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73120

Yukon, Oklahoma, United States, 73099

United States, Oregon

Lake Oswego, Oregon, United States, 97035

United States, Pennsylvania

Harrisburg, Pennsylvania, United States, 17110

United States, South Carolina

Greenville, South Carolina, United States, 29607

Orangeburg, South Carolina, United States, 29118

United States, Tennessee

Jackson, Tennessee, United States, 38301

United States, Texas

Carrollton, Texas, United States, 75010

United States, Utah

Salt Lake City, Utah, United States, 84102

United States, Virginia

Charlottesville, Virginia, United States, 22902

Richmond, Virginia, United States, 23229

Winchester, Virginia, United States, 22601

United States, Washington

Spokane, Washington, United States, 99202-1334

Argentina

Florencio Varela, Buenos Aires, Argentina, 1888

Buenos Aires, Capital Federal, Argentina, 1416

Buenos Aires, Capital Federal, Argentina, C1280AEB

Rosario, Santa Fé, Argentina, 2000

San Miguel de Tucumán, Tucumán, Argentina, 4000

Córdoba, Argentina, 5000

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer Healthcare products. 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00668304 History of Changes
• Other Study ID Numbers: 100569
• First Posted: April 29, 2008
• Last Update Posted: December 19, 2014
• Last Verified: December 2014

Keywords provided by Bayer:

Sinusitis

Additional relevant MeSH terms:

Moxifloxacin; Sinusitis; Maxillary Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Norgestimate, ethinyl estradiol drug combination; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs