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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01690533

Enrollment

497

Registered

2012-09-21

Start date

2008-05-13

Completion date

2013-07-19

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Infective Agents

Keywords

Avelox, Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in chronic respiratory diseases Sinusitis

Brief 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.

Interventions

DRUGAvelox (Moxifloxacin, BAY12-8039)

Patients treated with Moxifloxacin in daily clinical practice

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)	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.	After 7 days

Secondary

Measure	Time frame
ADR incidence rates classified by patient's background factors	After 7 days
Efficacy rates classified by patient's background factors	After 7 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026