Trial Condition(s):
Trial to evaluate time to symptom relief and elimination of infecting bacteria in treating sinusitis with Avelox (SPEED)
100569
Not Available
Not Available
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.
- 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
- 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
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Locations Investigative Site Buenos Aires (Capital Federal), Argentina, 1416 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Longmont, United States, 80501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Florencio Varela, Argentina, 1888 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Argentina, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fresno, United States, 93720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucumán, Argentina, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greenville, United States, 29607 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lake Oswego, United States, 97035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carrollton, United States, 75010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yukon, United States, 73099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Colorado Springs, United States, 80909 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bridgeport, United States, 06606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Miguel de Tucumán, Argentina, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charlottesville, United States, 22911 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hoover, United States, 35216-5453 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site North Massapequa, United States, 11758 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winchester, United States, 22601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Searcy, United States, 72143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shreveport, United States, 71105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orangeburg, United States, 29118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Harrisburg, United States, 17110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jonesboro, United States, 72401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43235 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salt Lake City, United States, 84102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riverside, United States, 92506 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jackson, United States, 38301 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DeLand, United States, 32720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oklahoma City, United States, 73120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99202-1334 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1