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VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis (VICTOR)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00876577
First received: April 3, 2009
Last updated: September 7, 2012
Last verified: September 2012
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Purpose
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 | Intervention |
|---|---|
| Chronic Bronchitis Disease Exacerbation | Drug: Moxifloxacin (Avelox, BAY12-8039) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms [ Time Frame: up to 21 days ]
Secondary Outcome Measures:
- Time to cure: time when symptoms are disappeared after Moxifloxacin treatment [ Time Frame: up to 21 days ]
- Improvement time: time when patients feel improvemen [ Time Frame: up to 21 days ]
- Time of patients recover from fever [ Time Frame: up to 21 days ]
- Clinical efficacy rate of Moxifloxacin [ Time Frame: up to 21 days ]
Biospecimen Retention: None Retained
n.a
| Enrollment: | 1206 |
| Study Start Date: | May 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876577
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876577
Locations
| China | |
| Many Locations, China | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
| Responsible Party: | Medical Director, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00876577 History of Changes |
| Other Study ID Numbers: |
14495 AX0810CN ( Other Identifier: Company internal ) |
| Study First Received: | April 3, 2009 |
| Last Updated: | September 7, 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 |
ClinicalTrials.gov processed this record on September 18, 2017