Avelox in Complicated Skin and Skin Structure Infections

NCT ID: NCT00997997

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Skin Diseases, Bacterial

Keywords

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Skin Diseases, Bacterial Product Surveillance Postmarketing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type DRUG

400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Austria

Site Status

Many Locations, , Bulgaria

Site Status

Many Locations, , Egypt

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Greece

Site Status

Many Locations, , Indonesia

Site Status

Many Locations, , Pakistan

Site Status

Many Locations, , Philippines

Site Status

Many Locations, , Saudi Arabia

Site Status

Many Locations, , Slovenia

Site Status

Many Locations, , South Korea

Site Status

Many Locations, , Taiwan

Site Status

Countries

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Austria Bulgaria Egypt Germany Greece Indonesia Pakistan Philippines Saudi Arabia Slovenia South Korea Taiwan

Other Identifiers

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12236 (AX0502DE)

Identifier Type: OTHER

Identifier Source: secondary_id

12237 (AX0502AT)

Identifier Type: OTHER

Identifier Source: secondary_id

12519 (AX0502SI)

Identifier Type: OTHER

Identifier Source: secondary_id

12645 (AX0502BG)

Identifier Type: OTHER

Identifier Source: secondary_id

12646 (AX0502PK)

Identifier Type: OTHER

Identifier Source: secondary_id

12754 (AX0502GR)

Identifier Type: OTHER

Identifier Source: secondary_id

12865 (AX0502KR)

Identifier Type: OTHER

Identifier Source: secondary_id

12866 (AX0502TW)

Identifier Type: OTHER

Identifier Source: secondary_id

13045 (AX0502ID)

Identifier Type: OTHER

Identifier Source: secondary_id

13165 (AX0502PH)

Identifier Type: OTHER

Identifier Source: secondary_id

13206 (AX0502EG)

Identifier Type: OTHER

Identifier Source: secondary_id

13924 (AX0502SA)

Identifier Type: OTHER

Identifier Source: secondary_id

12237

Identifier Type: -

Identifier Source: org_study_id