check_circleStudy Completed

Skin Diseases, Bacterial

Bayer Identifier:

12237

ClinicalTrials.gov Identifier:

NCT00997997

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

Both

Age

10 Years
  • - 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 are those specified in the local product information.

Trial summary

Enrollment Goal
6127
Trial Dates
October 2005 - December 2008
Phase
N/A
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 Avelox
    date_rangeTime Frame:
    last documented follow-up visit, according to the respective praxis routine
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    Safety Issue:
    No

Secondary Outcome

  • Adverse events collection
    date_rangeTime Frame:
    during entire study course, according to the respective praxis routine
    enhanced_encryption
    Safety Issue:
    Yes
  • Overall assessment of tolerability by the physician
    date_rangeTime Frame:
    last documented follow-up visit, according to the respective praxis routine
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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