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

Completed

• Conditions: Chronic Bronchitis; Disease Exacerbation
• Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Registration Number: NCT00876577
• Lead Sponsor: Bayer

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Study Start: 2009-05
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1206

Inclusion Criteria

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

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Moxifloxacin (Avelox, BAY12-8039)	-

Primary Outcome Measures

Name	Time	Method
clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms	up to 21 days

Secondary Outcome Measures

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