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

Fadoi Foundation, Italy

Status and phase: Completed; Phase 4

Conditions: COPD Exacerbation

Treatments: Drug: Prulifloxacin 1 tablet 600 mg once a day; Drug: Levofloxacin 1 tablet 500 mg once a day

Study type: Interventional

Funder types: Other

Identifiers

NCT01710488

EudraCT N. 2008-003842-27

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 258 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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258 participants in 2 patient groups

Levofloxacin 1 tablet 500 mg once a day

Active Comparator group

Description:

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

Treatment:

Drug: Levofloxacin 1 tablet 500 mg once a day

Prulifloxacin 1 tablet 600 mg once a day

Experimental group

Description:

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

Treatment:

Drug: Prulifloxacin 1 tablet 600 mg once a day