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Avelox in Complicated Skin and Skin Structure Infections (ARTOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997997
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : November 16, 2012
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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