Trial Condition(s):
Skin Diseases, Bacterial
Avelox in complicated skin and skin structure infections (ARTOS)
Bayer Identifier:
12237
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
- Exclusion criteria are those specified in the local product information.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Egypt | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Indonesia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Pakistan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Austria | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bulgaria | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovenia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
ARTOS - Avelox® in Routine Treatment of complicated Skin and Skin Structure Infections
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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 AveloxTimeframe: last documented follow-up visit, according to the respective praxis routine
Secondary Outcome
- Adverse events collectionTimeframe: during entire study course, according to the respective praxis routine
- Overall assessment of tolerability by the physicianTimeframe: last documented follow-up visit, according to the respective praxis routine
Additional Information
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