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

• ClinicalTrials.gov Identifier: NCT00876577
• Recruitment Status: Completed
• First Posted: April 6, 2009
• Last Update Posted: September 10, 2012
• Sponsor: Bayer
• 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

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

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