Trial Condition(s):

Maxillary Sinusitis

Trial to evaluate time to symptom relief and elimination of infecting bacteria in treating sinusitis with Avelox (SPEED)

Bayer Identifier:

100569

ClinicalTrials.gov Identifier:

NCT00668304

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
192
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Buenos Aires (Capital Federal), Argentina, 1416

Status
Completed
 
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Investigative Site

Longmont, United States, 80501

Status
Completed
 
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Investigative Site

Buenos Aires, Argentina, C1280AEB

Status
Completed
 
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Investigative Site

Florencio Varela, Argentina, 1888

Status
Completed
 
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Investigative Site

Rosario, Argentina, 2000

Status
Completed
 
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Investigative Site

Richmond, United States, 23229

Status
Completed
 
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Córdoba, Argentina, 5000

Status
Completed
 
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Fresno, United States, 93720

Status
Completed
 
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Investigative Site

Tucumán, Argentina, 4000

Status
Completed
 
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Greenville, United States, 29607

Status
Completed
 
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Investigative Site

Lake Oswego, United States, 97035

Status
Completed
 
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Carrollton, United States, 75010

Status
Completed
 
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Investigative Site

Yukon, United States, 73099

Status
Completed
 
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Colorado Springs, United States, 80909

Status
Completed
 
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Bridgeport, United States, 06606

Status
Completed
 
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San Miguel de Tucumán, Argentina, 4000

Status
Completed
 
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Investigative Site

Birmingham, United States, 35215

Status
Completed
 
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Investigative Site

Charlottesville, United States, 22911

Status
Completed
 
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Investigative Site

Hoover, United States, 35216-5453

Status
Completed
 
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Investigative Site

North Massapequa, United States, 11758

Status
Completed
 
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Investigative Site

Winchester, United States, 22601

Status
Completed
 
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Investigative Site

Searcy, United States, 72143

Status
Completed
 
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Investigative Site

Shreveport, United States, 71105

Status
Completed
 
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Investigative Site

Orangeburg, United States, 29118

Status
Completed
 
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Harrisburg, United States, 17110

Status
Completed
 
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Investigative Site

Jonesboro, United States, 72401

Status
Completed
 
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Investigative Site

Columbus, United States, 43235

Status
Completed
 
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Investigative Site

Salt Lake City, United States, 84102

Status
Completed
 
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Investigative Site

Riverside, United States, 92506

Status
Completed
 
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Investigative Site

Jackson, United States, 38301

Status
Completed
 
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Investigative Site

DeLand, United States, 32720

Status
Completed
 
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Investigative Site

Oklahoma City, United States, 73120

Status
Completed
 
Locations

Investigative Site

Spokane, United States, 99202-1334

Status
Completed
 

Trial Design