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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00876577

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:

MedlinePlus related topics: Chronic Bronchitis

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Effectiveness related variables will be sputum culture, defervescence time, time to improvement, time to cure, as well as the general assessment of effectiveness by physicians and general assessment of therapeutic effect by physicians and patients [ Time Frame: Baseline, Start of oral therapy, End of therapy ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

n.a

Enrollment:	1200
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

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:	March 11, 2011
Health Authority:	China: Ministry of Health

Keywords provided by Bayer:

Acute Exacerbations of Chronic Bronchitis
Avelox
Bronchitis

Additional relevant MeSH terms:

Bronchitis
Acute Disease
Bronchitis, Chronic
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-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012