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

NCT01690533 | Completed

• 1 other identifier: 16515
• Study Type: observational
• Target: 497
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti-Infective Agents

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• ADR incidence rates classified by patient's background factors

  After 7 days

• Efficacy rates classified by patient's background factors

  After 7 days

Study Arms (1)

Group 1

Drug: Avelox (Moxifloxacin, BAY12-8039)

Interventions

Avelox (Moxifloxacin, BAY12-8039) DRUG

Patients treated with Moxifloxacin in daily clinical practice

Group 1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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:
• 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

You may not qualify if:

• Patients who are contraindicated based on the product label.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Tonsillitis; Bronchitis; Pneumonia

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 21, 2012
• Study Start: May 13, 2008
• Primary Completion: December 14, 2010
• Study Completion: July 19, 2013
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

JP (1)