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

Anti-Infective Agents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690533
• Other study ID #: 16515
• Status: Completed
• Start date: May 13, 2008
• Est. completion date: July 19, 2013

Study information

• Verified date: May 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: July 19, 2013
• Est. primary completion date: December 14, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anti-Infective Agents
• Coinfection
• Infection
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Drug:
• Avelox (Moxifloxacin, BAY12-8039)
Patients treated with Moxifloxacin in daily clinical practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)		After 7 days
Primary	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.		After 7 days
Secondary	ADR incidence rates classified by patient's background factors		After 7 days
Secondary	Efficacy rates classified by patient's background factors		After 7 days

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