Avelox in Complicated Skin and Skin Structure Infections

Skin Diseases, Bacterial Clinical Trial

— ARTOS  

Official title:

ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997997
• Other study ID #: 12237
• Secondary ID: 12236 (AX0502DE)
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: November 14, 2012
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ministry of HealthBulgaria: Bulgarian Drug AgencyEgypt: Institutional Review BoardEgypt: Ministry of Health and PopulationEgypt: Ministry of Health, Drug Policy and Planning CenterGermany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareGreece: National Organization of MedicinesIndonesia: Departement Kesehatan (Department of Health)Indonesia: National Agency of Drug and Food ControlPakistan: Ministry of HealthPakistan: Research Ethics CommitteePhilippines: Department of HealthSaudi Arabia: Research Advisory CouncilSlovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics CommitteeSlovenia: Ministry of HealthSouth Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)Taiwan: Department of HealthTaiwan: Institutional Review BoardTaiwan: National Bureau of Controlled Drugs
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6127
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Skin Diseases
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Bulgaria,  Egypt,  Germany,  Greece,  Indonesia,  Korea, Republic of,  Pakistan,  Philippines,  Saudi Arabia,  Slovenia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		last documented follow-up visit, according to the respective praxis routine	No
Secondary	Adverse events collection		during entire study course, according to the respective praxis routine	Yes
Secondary	Overall assessment of tolerability by the physician		last documented follow-up visit, according to the respective praxis routine	No

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