Clinical trial NCT00668304: Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Maxillary Sinusitis
Keywords: Sinusitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae
timeFrame: Days 1, 2, 3 of treatment
Secondary outcomes:
measure: Patient-reported symptom improvement using SNOT-16 questionnaire
timeFrame: Up to End of Treatment (Day 10-13)
measure: Clinical Response
timeFrame: End of Treatment
measure: Bacteriological Response
timeFrame: End of Treatment
measure: Activity Impairment Assessment questionnaire
timeFrame: Up to End of Treatment (Day 10-13)
measure: Incidence of Premature Termination
timeFrame: Premature Termination
measure: Adverse Events Collection
timeFrame: Up to End of Treatment (Day 10-13)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hoover
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: Searcy
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: DeLand
country: United States
state: Florida
city: Shreveport
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: North Massapequa
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Yukon
country: United States
state: Oklahoma
city: Lake Oswego
country: United States
state: Oregon
city: Harrisburg
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Carrollton
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Florencio Varela
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Rosario
country: Argentina
state: Santa Fé
city: San Miguel de Tucumán
country: Argentina
state: Tucumán
city: Córdoba
country: Argentina
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: