Avelox in Complicated Skin and Skin Structure Infections (ARTOS)

November 14, 2012 updated by: Bayer

ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being diagnosed with complicated skin and skin structure infections, mainly in hospital settings

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Moxifloxacin (Avelox, BAY12-8039)
400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: last documented follow-up visit, according to the respective praxis routine
last documented follow-up visit, according to the respective praxis routine

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events collection
Time Frame: during entire study course, according to the respective praxis routine
during entire study course, according to the respective praxis routine
Overall assessment of tolerability by the physician
Time Frame: last documented follow-up visit, according to the respective praxis routine
last documented follow-up visit, according to the respective praxis routine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (Estimate)

October 20, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12237
  • 12236 (AX0502DE) (Other Identifier: Company)
  • 12237 (AX0502AT) (Other Identifier: Company)
  • 12519 (AX0502SI) (Other Identifier: Company)
  • 12645 (AX0502BG) (Other Identifier: Company)
  • 12646 (AX0502PK) (Other Identifier: Company)
  • 12754 (AX0502GR) (Other Identifier: Company)
  • 12865 (AX0502KR) (Other Identifier: Company)
  • 12866 (AX0502TW) (Other Identifier: Company)
  • 13045 (AX0502ID) (Other Identifier: Company)
  • 13165 (AX0502PH) (Other Identifier: Company)
  • 13206 (AX0502EG) (Other Identifier: Company)
  • 13924 (AX0502SA) (Other Identifier: Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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