check_circleStudy 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
  • - 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


  • - 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
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

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

Secondary Outcome

  • ADR incidence rates classified by patient’s background factors
    date_rangeTime Frame:
    After 7 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Efficacy rates classified by patient’s background factors
    date_rangeTime Frame:
    After 7 days
    enhanced_encryption
    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.