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

Tracking Information

First Received Date ^ICMJE

April 3, 2009

Last Updated Date

September 7, 2012

Start Date ^ICMJE

May 2009

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00876577 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: None Retained

Description:

n.a

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.

Condition ^ICMJE

Chronic Bronchitis
Disease Exacerbation

Intervention ^ICMJE

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

Study Group/Cohort (s)

Group 1

Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1206

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00876577

Other Study ID Numbers ^ICMJE

14495, AX0810CN

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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