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Avelox in Complicated Skin and Skin Structure Infections (ARTOS)

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997997


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

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00997997     History of Changes
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    Key Record Dates
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
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
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
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs