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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 2009
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Time to cure: time when symptoms are disappeared after Moxifloxacin treatment [ Time Frame: up to 21 days ]
2. Improvement time: time when patients feel improvemen [ Time Frame: up to 21 days ]
3. Time of patients recover from fever [ Time Frame: up to 21 days ]
4. Clinical efficacy rate of Moxifloxacin [ Time Frame: up to 21 days ]

Biospecimen Retention:   None Retained

n.a

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China
Many Locations, China

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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Responsible Party:	Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00876577 History of Changes
Other Study ID Numbers:	14495; AX0810CN ( Other Identifier: Company internal )
First Posted:	April 6, 2009
Last Update Posted:	September 10, 2012
Last Verified:	September 2012

Keywords provided by Bayer:

Acute Exacerbations of Chronic Bronchitis; Avelox; Bronchitis

Additional relevant MeSH terms:

Bronchitis; Bronchitis, Chronic; Acute Disease; Disease Progression; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections; Disease Attributes; Pathologic Processes; Pulmonary Disease, Chronic Obstructive; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination	Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs