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

Completed

• Conditions: Anti-Infective Agents
• Interventions: Drug: Avelox (Moxifloxacin, BAY12-8039)

• Registration Number: NCT01690533
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-13
• Primary Completion: 2010-12-14
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-21
• Study Completion: 2013-07-19
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 497

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

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Exclusion Criteria

• Patients who are contraindicated based on the product label.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)	After 7 days

Secondary Outcome Measures

Name	Time	Method
ADR incidence rates classified by patient's background factors	After 7 days
Efficacy rates classified by patient's background factors	After 7 days