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

Chronic Bronchitis Clinical Trial

— VICTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876577
• Other study ID #: 14495
• Secondary ID: AX0810CN
• Status: Completed
• Phase: N/A
• First received: April 3, 2009
• Last updated: September 7, 2012
• Start date: May 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1206
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms		up to 21 days	No
Secondary	Time to cure: time when symptoms are disappeared after Moxifloxacin treatment		up to 21 days	No
Secondary	Improvement time: time when patients feel improvemen		up to 21 days	No
Secondary	Time of patients recover from fever		up to 21 days	No
Secondary	Clinical efficacy rate of Moxifloxacin		up to 21 days	No

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