Study Completed

Anti-Infective Agents

Bayer Identifier:

16515

ClinicalTrials.gov Identifier:

NCT01690533

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A

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

May 2008 - July 2013

Phase

N/A

Could I Receive a placebo

Products

Avelox (Moxifloxacin hydrochloride, BAY12-8039)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Japan

Primary Outcome

Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)
Time Frame:
After 7 days
Safety Issue:
Yes
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.
Time Frame:
After 7 days
Safety Issue:
No

Secondary Outcome

ADR incidence rates classified by patient’s background factors
Time Frame:
After 7 days
Safety Issue:
Yes
Efficacy rates classified by patient’s background factors
Time Frame:
After 7 days
Safety Issue:
No

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

N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.