Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD

Study Overview
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Brief Summary
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The primary objective of the study is to determine the percentage of patients with therapeutic success at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)

Detailed Description
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The aim of this study was to examine the effects of the use of fluoroquinolones a class of antibiotics introduced relatively recently, in a particular population of patients with acute exacerbation of COPD, previously treated unsuccessfully with other antibiotics, and hospitalized in Internal Medicine. These patients reflect the reality of patients admitted to Internal Medicine, they are characterized by a high frequency of advanced age, polypathology, with multiple treatments.

Official Title
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A Randomized, Controlled, Single-blind, Parallel-group Comparison Between Levofloxacin and Prulifloxacin, in Patients With Acute Exacerbation of COPD Unresponsive to Other Antibiotics and Admitted to the Internal Medicine

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Drug: Levofloxacin 1 tablet 500 mg once a day
* Drug: Prulifloxacin 1 tablet 600 mg once a day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp Med 2005), plus at least two of the following signs-symptoms Increased cough Increased dyspnea Increase in sputum volume appeared at least 3 days previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital ≥ 60 years FEV1 <80% and ≥ 30% and ratio FEV 1 / FVC <70% chest x-ray negative for inflammatory infiltrates informed consent Exclusion Criteria: asthma pulmonary neoplasms a history of allergy or hypersensitivity to quinolones impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months) history of tendinopathy note or severe renal impairment creatinine> than twice the upper limit of the normal range or hepatic impairment (AST and / or ALT> twice the upper limit of the normal range) patients with sepsis, tuberculosis or other infections in other organs or systems cystic fibrosis patients with inherited tolerance to intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase pregnant or breastfeeding drug or alcohol addiction experimental concomitant treatment with other drugs

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levofloxacin 1 tablet 500 mg once a day<br>Levofloxacin 1 tablet 500 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients | Drug: Levofloxacin 1 tablet 500 mg once a day<br>* Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients: Levofloxacin 500 mg (1 tablet) once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.<br>* Other names: LEVOXACIN 500 mg;|
| Experimental: Prulifloxacin 1 tablet 600 mg once a day<br>Prulifloxacin 1 tablet 600 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients | Drug: Prulifloxacin 1 tablet 600 mg once a day<br>* Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients: Prulifloxacin 1 tablet 600 mg once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.<br>* Other names: UNIDROX 600 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to determine the percentage of patients with therapeutic success at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). | The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of successful treatment to day 7 of treatment |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD exacerbation, fluoroquinolones,