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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Special Drug Use Investigation - Assessment of efficacy and safety in treating secondary infection of chronic respiratory disease
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)Timeframe: 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.Timeframe: After 7 days
Secondary Outcome
- ADR incidence rates classified by patient’s background factorsTimeframe: After 7 days
- Efficacy rates classified by patient’s background factorsTimeframe: After 7 days
Additional Information
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