Completed

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

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What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Bronchial Diseases+10

+ Infections

+ Lung Diseases

Over 20 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: May 2008
See protocol details

Summary

Principal SponsorBayer
Last updated: May 21, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: May 13, 2008

Actual date on which the first participant was enrolled.

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.

NCT01690533
Principal SponsorBayer
Last updated: May 21, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

497 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesInfectionsLung DiseasesLung Diseases, ObstructiveStomatognathic DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesPharyngitisRespiratory Tract DiseasesRespiratory Tract InfectionsBronchitisPneumoniaTonsillitis

Criteria

4 inclusion criteria required to participate
20 years old or older
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 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
with infection of mild or moderate severity
1 exclusion criteria prevent from participating
Patients who are contraindicated based on the product label

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Multiple Locations, JapanOpen in Google Maps
CompletedOne Study Center