Avelox in Complicated Skin and Skin Structure Infections

Completed

• Conditions: Skin Diseases, Bacterial
• Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Registration Number: NCT00997997
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-14
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6127

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.

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Exclusion Criteria

• Exclusion criteria are those specified in the local product information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Moxifloxacin (Avelox, BAY12-8039)	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	during entire study course, according to the respective praxis routine
Overall assessment of tolerability by the physician	last documented follow-up visit, according to the respective praxis routine