Clinical Trial: VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis

Brief Summary: This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from an acute exacerbation of chronic bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely prescribed. The secondary objective is to find out the possible correlation between the risk factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different treatment effectiveness according to Anthonisen classification. This study will also collect the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection in treating Acute Exacerbations of Chronic Bronchitis (AECB).

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms [ Time Frame: up to 21 days ]

Original Primary Outcome: Effectiveness related variables will be sputum culture, defervescence time, time to improvement, time to cure, as well as the general assessment of effectiveness by physicians and general assessment of therapeutic effect by physicians and patients [ Time Frame: Baseline, Start of oral therapy, End of therapy ]

Current Secondary Outcome:

  • Time to cure: time when symptoms are disappeared after Moxifloxacin treatment [ Time Frame: up to 21 days ]
  • Improvement time: time when patients feel improvemen [ Time Frame: up to 21 days ]
  • Time of patients recover from fever [ Time Frame: up to 21 days ]
  • Clinical efficacy rate of Moxifloxacin [ Time Frame: up to 21 days ]


Original Secondary Outcome:

Information By: Bayer

Dates:
Date Received: April 3, 2009
Date Started: May 2009
Date Completion:
Last Updated: September 7, 2012
Last Verified: September 2012