Avelox in Complicated Skin and Skin Structure Infections
ARTOS
ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections
13 other identifiers
observational
6,127
12 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2005
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 2, 2009
CompletedFirst Posted
Study publicly available on registry
October 20, 2009
CompletedNovember 16, 2012
November 1, 2012
3.2 years
October 2, 2009
November 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
Group 1
Interventions
400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information
Eligibility Criteria
Patients being diagnosed with complicated skin and skin structure infections, mainly in hospital settings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (12)
Unknown Facility
Many Locations, Austria
Unknown Facility
Many Locations, Bulgaria
Unknown Facility
Many Locations, Egypt
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, Greece
Unknown Facility
Many Locations, Indonesia
Unknown Facility
Many Locations, Pakistan
Unknown Facility
Many Locations, Philippines
Unknown Facility
Many Locations, Saudi Arabia
Unknown Facility
Many Locations, Slovenia
Unknown Facility
Many Locations, South Korea
Unknown Facility
Many Locations, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 2, 2009
First Posted
October 20, 2009
Study Start
October 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 16, 2012
Record last verified: 2012-11