Skin Diseases, Bacterial
Conditions
Keywords
Skin Diseases, Bacterial, Product Surveillance, Postmarketing
Brief summary
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.
Interventions
400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Avelox | last documented follow-up visit, according to the respective praxis routine |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events collection | during entire study course, according to the respective praxis routine |
| Overall assessment of tolerability by the physician | last documented follow-up visit, according to the respective praxis routine |
Countries
Austria, Bulgaria, Egypt, Germany, Greece, Indonesia, Pakistan, Philippines, Saudi Arabia, Slovenia, South Korea, Taiwan
Outcome results
None listed