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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00876577
First received: April 3, 2009
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to cure: time when symptoms are disappeared after Moxifloxacin treatment [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Improvement time: time when patients feel improvemen [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Time of patients recover from fever [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Clinical efficacy rate of Moxifloxacin [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00876577     History of Changes
Other Study ID Numbers: 14495, AX0810CN
Study First Received: April 3, 2009
Last Updated: September 7, 2012
Health Authority: China: Ministry of Health

Keywords provided by Bayer:
Acute Exacerbations of Chronic Bronchitis
Avelox
Bronchitis

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Bronchial Diseases
Lung Diseases
 Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 27, 2015