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

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ClinicalTrials.gov Identifier: NCT00668304
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 25, 2008
First Posted Date  ICMJE April 29, 2008
Last Update Posted Date December 19, 2014
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
Time to bacteriological eradication in those who are microbiologically valid for S. pneumoniae, M. catarrhalis, and H. influenzae [ Time Frame: Days 1, 2, 3 of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
  • Patient-reported symptom improvement using SNOT-16 questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
  • Clinical Response [ Time Frame: End of Treatment ]
  • Bacteriological Response [ Time Frame: End of Treatment ]
  • Activity Impairment Assessment questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
  • Incidence of Premature Termination [ Time Frame: Premature Termination ]
  • Adverse Events Collection [ Time Frame: Up to End of Treatment (Day 10-13) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
  • Patient-reported symptom improvement using SNOT-16 questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
  • Clinical Response [ Time Frame: End of Treatment ]
  • Bacteriological Response [ Time Frame: End of Treatment ]
  • Activity Impairment Assessment questionnaire [ Time Frame: Up to End of Treatment (Day 10-13) ]
  • Incidence of Premature Termination [ Time Frame: Premature Termination ]
  • Adverse Events [ Time Frame: Up to End of Treatment (Day 10-13) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Maxillary Sinusitis
Intervention  ICMJE Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg once orally daily
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2014)
192
Original Actual Enrollment  ICMJE
 (submitted: April 28, 2008)
200
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00668304
Other Study ID Numbers  ICMJE 100569
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP