check_circleStudy Completed
Chronic Bronchitis, Disease Exacerbation
Bayer Identifier:
14495
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
VICTOR - Avelox® intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis
Trial 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).
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1206Trial Dates
May 2009 - March 2011Phase
N/ACould I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, China |
Primary Outcome
- clinical cure rate:clinical cure was defined as disappearance of acute signs and symptomsdate_rangeTime Frame:up to 21 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time to cure: time when symptoms are disappeared after Moxifloxacin treatmentdate_rangeTime Frame:up to 21 daysenhanced_encryptionNoSafety Issue:
- Improvement time: time when patients feel improvemendate_rangeTime Frame:up to 21 daysenhanced_encryptionNoSafety Issue:
- Time of patients recover from feverdate_rangeTime Frame:up to 21 daysenhanced_encryptionNoSafety Issue:
- Clinical efficacy rate of Moxifloxacindate_rangeTime Frame:up to 21 daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A