Avelox in Complicated Skin and Skin Structure Infections (ARTOS)

• ClinicalTrials.gov Identifier: NCT00997997
• Recruitment Status: Completed
• First Posted: October 20, 2009
• Last Update Posted: November 16, 2012
• Sponsor: Bayer
• Information provided by: Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Skin Diseases, Bacterial	Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Design

• Study Type: Observational
• Actual Enrollment: 6127 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections
• Study Start Date: October 2005
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 10 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Locations

Austria

Many Locations, Austria

Bulgaria

Many Locations, Bulgaria

Egypt

Many Locations, Egypt

Germany

Many Locations, Germany

Greece

Many Locations, Greece

Indonesia

Many Locations, Indonesia

Korea, Republic of

Many Locations, Korea, Republic of

Pakistan

Many Locations, Pakistan

Philippines

Many Locations, Philippines

Saudi Arabia

Many Locations, Saudi Arabia

Slovenia

Many Locations, Slovenia

Taiwan

Many Locations, Taiwan

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
• ClinicalTrials.gov Identifier: NCT00997997
• 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 )
• First Posted: October 20, 2009
• Last Update Posted: November 16, 2012
• Last Verified: November 2012

Keywords provided by Bayer:

Skin Diseases, Bacterial; Product Surveillance; Postmarketing

Additional relevant MeSH terms:

Skin Diseases, Bacterial; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female