- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876577
VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis (VICTOR)
September 7, 2012 updated by: Bayer
VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1206
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Many Locations, China
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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Patients from the normal praxis routine, treated with Moxifloxacin injection with/without sequential tablet treatment according to the local product information
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms
Time Frame: up to 21 days
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up to 21 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to cure: time when symptoms are disappeared after Moxifloxacin treatment
Time Frame: up to 21 days
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up to 21 days
|
Improvement time: time when patients feel improvemen
Time Frame: up to 21 days
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up to 21 days
|
Time of patients recover from fever
Time Frame: up to 21 days
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up to 21 days
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Clinical efficacy rate of Moxifloxacin
Time Frame: up to 21 days
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up to 21 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
April 3, 2009
First Submitted That Met QC Criteria
April 3, 2009
First Posted (Estimate)
April 6, 2009
Study Record Updates
Last Update Posted (Estimate)
September 10, 2012
Last Update Submitted That Met QC Criteria
September 7, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Bronchial Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Disease Progression
- Acute Disease
- Bronchitis
- Bronchitis, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
Other Study ID Numbers
- 14495
- AX0810CN (Other Identifier: Company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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