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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00876577
• Collaborator: (none)
• Enrollment: 1,206
• Location: 1
• Duration (Months): 22
• Patients Per Site Per Month: 54.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Bronchitis; Disease Exacerbation	Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Design

• Study Type: Observational
• Actual Enrollment: 1206 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Group 1	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

Outcome Measures

Primary Outcome Measures

1. clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms [up to 21 days]

Secondary Outcome Measures

1. Time to cure: time when symptoms are disappeared after Moxifloxacin treatment [up to 21 days]

2. Improvement time: time when patients feel improvemen [up to 21 days]

3. Time of patients recover from fever [up to 21 days]

4. Clinical efficacy rate of Moxifloxacin [up to 21 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		China

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00876577
• Other Study ID Numbers: 14495; AX0810CN
• First Posted: Apr 6, 2009
• Last Update Posted: Sep 10, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by , ,: Acute Exacerbations of Chronic Bronchitis; Avelox; Bronchitis
• Additional relevant MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease; Disease Progression; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Sep 10, 2012