Avelox in Complicated Skin and Skin Structure Infections (ARTOS)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00997997
First received: October 2, 2009
Last updated: November 14, 2012
Last verified: November 2012
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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
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-Infective Agents |
Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013