check_circleStudy Completed
Skin Diseases, Bacterial
Bayer Identifier:
12237
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Avelox in complicated skin and skin structure infections
Trial purpose
This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.
Key Participants Requirements
Sex
BothAge
10 YearsTrial summary
Enrollment Goal
6127Trial Dates
October 2005 - December 2008Phase
N/ACould I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Egypt | |
Completed | Many Locations, Greece | |
Completed | Many Locations, Indonesia | |
Completed | Many Locations, Philippines | |
Completed | Many Locations, Pakistan | |
Completed | Many Locations, Saudi Arabia | |
Completed | Many Locations, Republic of Korea | |
Completed | Many Locations, Austria | |
Completed | Many Locations, Bulgaria | |
Completed | Many Locations, Germany | |
Completed | Many Locations, Slovenia | |
Completed | Many Locations, Taiwan |
Primary Outcome
- Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Aveloxdate_rangeTime Frame:last documented follow-up visit, according to the respective praxis routineenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Adverse events collectiondate_rangeTime Frame:during entire study course, according to the respective praxis routineenhanced_encryptionYesSafety Issue:
- Overall assessment of tolerability by the physiciandate_rangeTime Frame:last documented follow-up visit, according to the respective praxis routineenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A