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NCT Number: NCT00876577

VICTOR - Avelox® Intravenous (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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: up to 21 days

Secondary outcomes

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

    Time frame: up to 21 days

  2. Improvement time: time when patients feel improvemen

    Time frame: up to 21 days

  3. Time of patients recover from fever

    Time frame: up to 21 days

  4. Clinical efficacy rate of Moxifloxacin

    Time frame: up to 21 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: VICTOR

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2009
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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