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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00876577
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : September 10, 2012
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date April 3, 2009
First Posted Date April 6, 2009
Last Update Posted Date September 10, 2012
Study Start Date May 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2012)
clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms [ Time Frame: up to 21 days ]
Original Primary Outcome Measures
 (submitted: April 3, 2009)
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 ]
Change History Complete list of historical versions of study NCT00876577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 7, 2012)
  • 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 Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis
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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
n.a
Sampling Method Non-Probability Sample
Study Population Adult female and male patients with AECB, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin injection, independent of the duration and severity of the underlying chronic bronchitis, can be documented after the therapy decision has been made.
Condition
  • Chronic Bronchitis
  • Disease Exacerbation
Intervention Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients from the normal praxis routine, treated with Moxifloxacin injection with/without sequential tablet treatment according to the local product information
Study Groups/Cohorts Group 1
Intervention: Drug: Moxifloxacin (Avelox, 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 Completed
Actual Enrollment
 (submitted: September 7, 2012)
1206
Original Estimated Enrollment
 (submitted: April 3, 2009)
1200
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients at least 18 years of age with a diagnosis of AECB treated with Moxifloxacin injection with/without sequential tablet treatment

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00876577
Other Study ID Numbers 14495
AX0810CN ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical Director, Bayer Healthcare AG
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2012