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

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

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.

Study Overview

• Status: Completed
• Conditions: Maxillary Sinusitis
• Intervention / Treatment: Drug: Avelox (Moxifloxacin, BAY12-8039)

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5000
  • Buenos Aires
    • Florencio Varela, Buenos Aires, Argentina, 1888
  • Capital Federal
    • Buenos Aires, Capital Federal, Argentina, 1416
    • Buenos Aires, Capital Federal, Argentina, C1280AEB
  • Santa Fé
    • Rosario, Santa Fé, Argentina, 2000
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, 4000
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35206
    • Hoover, Alabama, United States, 35216-5453
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
    • Searcy, Arkansas, United States, 72143
  • California
    • Fresno, California, United States, 93720
    • Riverside, California, United States, 92506
    • San Francisco, California, United States, 94102
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
    • Longmont, Colorado, United States, 80501
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
  • Florida
    • DeLand, Florida, United States, 32720-2560
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
  • Michigan
    • Detroit, Michigan, United States, 48202
  • New York
    • North Massapequa, New York, United States, 11758
    • Rochester, New York, United States, 14618
  • Ohio
    • Columbus, Ohio, United States, 43235
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
    • Yukon, Oklahoma, United States, 73099
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
  • South Carolina
    • Greenville, South Carolina, United States, 29607
    • Orangeburg, South Carolina, United States, 29118
  • Tennessee
    • Jackson, Tennessee, United States, 38301
  • Texas
    • Carrollton, Texas, United States, 75010
  • Utah
    • Salt Lake City, Utah, United States, 84102
  • Virginia
    • Charlottesville, Virginia, United States, 22902
    • Richmond, Virginia, United States, 23229
    • Winchester, Virginia, United States, 22601
  • Washington
    • Spokane, Washington, United States, 99202-1334

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Adverse Events Collection	Up to End of Treatment (Day 10-13)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: April 25, 2008
• First Submitted That Met QC Criteria: April 28, 2008
• First Posted (Estimate): April 29, 2008

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Sinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Maxillary Sinusitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 100569 (Other Identifier: GSK)