Skip to main content
OpenTrials
Completed

NCT Number: NCT00997997

Avelox in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin (Avelox, BAY12-8039)

Drug

400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information

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

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

Secondary outcomes

  1. Adverse events collection

    Time frame: during entire study course, according to the respective praxis routine

  2. Overall assessment of tolerability by the physician

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: ARTOS

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 20, 2009
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.