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

Tracking Information

• First Submitted Date: October 2, 2009
• First Posted Date: October 20, 2009
• Last Update Posted Date: November 16, 2012
• Study Start Date: October 2005
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 19, 2009): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 19, 2009)

• Adverse events collection [ Time Frame: 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Avelox in Complicated Skin and Skin Structure Infections
• Official Title: ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients being diagnosed with complicated skin and skin structure infections, mainly in hospital settings
• Condition: Skin Diseases, Bacterial

Intervention

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

Study Groups/Cohorts

Group 1

Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 21, 2011): 6127
• Original Enrollment (submitted: October 19, 2009): 6300
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Bulgaria, Egypt, Germany, Greece, Indonesia, Korea, Republic of, Pakistan, Philippines, Saudi Arabia, Slovenia, Taiwan

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
• Study Sponsor: Bayer
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: November 2012