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

Bayer

Status: Completed

Conditions: Anti-Infective Agents

Treatments: Drug: Avelox (Moxifloxacin, BAY12-8039)

Study type: Observational

Funder types: Industry

Identifiers

NCT01690533

16515

Details and patient eligibility

About

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.

Enrollment: 497 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 design

497 participants in 1 patient group

Group 1

Treatment:

Drug: Avelox (Moxifloxacin, BAY12-8039)