Trial Condition(s):

Anti-Infective Agents

Special Drug Use Investigation - Assessment of efficacy and safety in treating secondary infection of chronic respiratory disease

Bayer Identifier:

16515

ClinicalTrials.gov Identifier:

NCT01690533

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
497
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design