Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease

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

497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-13

Study Completion Date

2013-07-19

Brief Summary

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The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg (hereinafter as "Avelox") in treating secondary infection of chronic respiratory disease.It is a local prospective and observational study of patients who have received Avelox tablets for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and assessed during the period of treatment with Avelox.

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Detailed Description

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Conditions

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Anti-Infective Agents

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type DRUG

Patients treated with Moxifloxacin in daily clinical practice

Interventions

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Avelox (Moxifloxacin, BAY12-8039)

Patients treated with Moxifloxacin in daily clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with secondary infection of chronic respiratory disease (excluding acute bronchitis patients who have been determined to be without chronic respiratory tract disease based on their medical history, x-ray findings, and/or other findings) who meet the following criteria:
* 20 years old or older
* with infection of mild or moderate severity
* Patients who meet the following criteria immediately before starting the therapy: ≥37°C of body temperature, expectoration of purulent or mucopurulent sputum, and either white blood cell count ≥8,000/mm3 or CRP ≥0.7 mg/dL