Avelox in Complicated Skin and Skin Structure Infections (ARTOS)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00997997
First received: October 2, 2009
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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 Intervention
Skin Diseases, Bacterial
Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: during entire study course, according to the respective praxis routine ] [ Designated as safety issue: Yes ]
  • Overall assessment of tolerability by the physician [ Time Frame: last documented follow-up visit, according to the respective praxis routine ] [ Designated as safety issue: No ]

Enrollment: 6127
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00997997     History of Changes
Other Study ID Numbers: 12237, 12236 (AX0502DE), 12237 (AX0502AT), 12519 (AX0502SI), 12645 (AX0502BG), 12646 (AX0502PK), 12754 (AX0502GR), 12865 (AX0502KR), 12866 (AX0502TW), 13045 (AX0502ID), 13165 (AX0502PH), 13206 (AX0502EG), 13924 (AX0502SA)
Study First Received: October 2, 2009
Last Updated: November 14, 2012
Health Authority: Austria: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Egypt: Institutional Review Board
Egypt: Ministry of Health and Population
Egypt: Ministry of Health, Drug Policy and Planning Center
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Indonesia: Departement Kesehatan (Department of Health)
Indonesia: National Agency of Drug and Food Control
Pakistan: Ministry of Health
Pakistan: Research Ethics Committee
Philippines: Department of Health
Saudi Arabia: Research Advisory Council
Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee
Slovenia: Ministry of Health
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs

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
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 19, 2014