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

Study Overview
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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.

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

Conditions
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Anti-Infective Agents

Intervention / Treatment
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* Drug: Avelox (Moxifloxacin, BAY12-8039)


Participation Criteria
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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 Exclusion Criteria: Patients who are contraindicated based on the product label.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Avelox (Moxifloxacin, BAY12-8039)<br>* Patients treated with Moxifloxacin in daily clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse drug reactions (ADRs) and serious adverse events (SAEs) |  | After 7 days | 
| Clinical efficacy rate (Response, Minor Response, No Response and Indeterminable) assessed by investigator's discretion. Efficacy rate is calculated as number of patients with Response or Minor Response proportional to number of all cases. |  | After 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR incidence rates classified by patient's background factors |  | After 7 days | 
| Efficacy rates classified by patient's background factors |  | After 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avelox, Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in chronic respiratory diseases Sinusitis