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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876577
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : September 10, 2012
Information provided by:

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)

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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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876577

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Many Locations, China
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Medical Director, Bayer Healthcare AG Identifier: NCT00876577    
Other Study ID Numbers: 14495
AX0810CN ( Other Identifier: Company internal )
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by Bayer:
Acute Exacerbations of Chronic Bronchitis
Additional relevant MeSH terms:
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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
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