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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Bayer

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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:

  • 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) ]


Information By: Bayer

Dates:
Date Received: April 25, 2008
Date Started: June 2004
Date Completion:
Last Updated: December 18, 2014
Last Verified: December 2014