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

NCT00668304 | Completed Phase 4

• 1 other identifier: 100569
• Study Type: interventional
• Target: 192
• Locations: 2 countries
• Sites: 35

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.

Conditions

Maxillary Sinusitis

Keywords

Sinusitis

Outcome Measures

Primary Outcomes (1)

• Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae

  Days 1, 2, 3 of treatment

Secondary Outcomes (6)

• Patient-reported symptom improvement using SNOT-16 questionnaire

  Up to End of Treatment (Day 10-13)

• Clinical Response

  End of Treatment

• Bacteriological Response

  End of Treatment

• Activity Impairment Assessment questionnaire

  Up to End of Treatment (Day 10-13)

• Incidence of Premature Termination

  Premature Termination

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Avelox (Moxifloxacin, BAY12-8039)

Interventions

Avelox (Moxifloxacin, BAY12-8039) DRUG

Moxifloxacin 400 mg once orally daily

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (35)

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Birmingham, Alabama, 35206, United States

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Hoover, Alabama, 35216-5453, United States

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Jonesboro, Arkansas, 72401, United States

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Searcy, Arkansas, 72143, United States

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Fresno, California, 93720, United States

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Riverside, California, 92506, United States

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San Francisco, California, 94102, United States

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Colorado Springs, Colorado, 80909, United States

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Longmont, Colorado, 80501, United States

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Bridgeport, Connecticut, 06606, United States

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DeLand, Florida, 32720-2560, United States

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Shreveport, Louisiana, 71105, United States

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Detroit, Michigan, 48202, United States

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North Massapequa, New York, 11758, United States

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Rochester, New York, 14618, United States

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Columbus, Ohio, 43235, United States

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Oklahoma City, Oklahoma, 73120, United States

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Yukon, Oklahoma, 73099, United States

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Lake Oswego, Oregon, 97035, United States

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Harrisburg, Pennsylvania, 17110, United States

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Greenville, South Carolina, 29607, United States

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Orangeburg, South Carolina, 29118, United States

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Jackson, Tennessee, 38301, United States

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Carrollton, Texas, 75010, United States

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Salt Lake City, Utah, 84102, United States

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Charlottesville, Virginia, 22902, United States

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Richmond, Virginia, 23229, United States

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Winchester, Virginia, 22601, United States

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Spokane, Washington, 99202-1334, United States

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San Juan Bautista, Buenos Aires, 1888, Argentina

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Buenos Aires, Buenos Aires F.D., 1416, Argentina

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Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

MeSH Terms

Conditions

Maxillary Sinusitis; Sinusitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: June 1, 2004
• Study Completion: January 1, 2005
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (29); AR (6)