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

NCT00876577 | Completed

• 2 other identifiers: 14495AX0810CN
• Study Type: observational
• Target: 1,206
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Bronchitis; Disease Exacerbation

Keywords

Acute Exacerbations of Chronic Bronchitis; Avelox; Bronchitis

Outcome Measures

Primary Outcomes (1)

• clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms

  up to 21 days

Secondary Outcomes (4)

• Time to cure: time when symptoms are disappeared after Moxifloxacin treatment

  up to 21 days

• Improvement time: time when patients feel improvemen

  up to 21 days

• Time of patients recover from fever

  up to 21 days

• Clinical efficacy rate of Moxifloxacin

  up to 21 days

Study Arms (1)

Group 1

Drug: Moxifloxacin (Avelox, BAY12-8039)

Interventions

Moxifloxacin (Avelox, BAY12-8039) DRUG

Patients from the normal praxis routine, treated with Moxifloxacin injection with/without sequential tablet treatment according to the local product information

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients at least 18 years of age with a diagnosis of AECB treated with Moxifloxacin injection with/without sequential tablet treatment

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Conditions

Bronchitis, Chronic; Disease Progression; Bronchitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 10, 2012

Record last verified: 2012-09

Locations

CN (1)