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

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.

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Key information

Conditions

Anti-Infective Agents Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tonsillitis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avelox (Moxifloxacin, BAY12-8039)

Drug

Patients treated with Moxifloxacin in daily clinical practice

Primary outcomes

Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)

Time frame: 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.

Time frame: After 7 days

Secondary outcomes

ADR incidence rates classified by patient's background factors

Time frame: After 7 days
Efficacy rates classified by patient's background factors

Time frame: After 7 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2013
First posted: Sep 21, 2012
Registry last updated: May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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