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

NCT ID: NCT01710488

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-11-30

Brief Summary

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

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.

Conditions

COPD Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Levofloxacin 1 tablet 500 mg once a day

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

Group Type: ACTIVE_COMPARATOR

Levofloxacin 1 tablet 500 mg once a day

Intervention Type: DRUG

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.

Prulifloxacin 1 tablet 600 mg once a day

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

Group Type: EXPERIMENTAL

Prulifloxacin 1 tablet 600 mg once a day

Intervention Type: DRUG

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.

Interventions

Levofloxacin 1 tablet 500 mg once a day

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.

Intervention Type: DRUG

Prulifloxacin 1 tablet 600 mg once a day

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.

Intervention Type: DRUG

Other Intervention Names

LEVOXACIN 500 mg; UNIDROX 600 mg

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fadoi Foundation, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gualberto GG Gussoni, MD, PhD

Role: STUDY_DIRECTOR

Dept. Clinical Research "Study Centre" - FadoiFoundation

Locations

Hospita "San Francesco Caracciolo"

Agnone, , Italy

Hospital of Alghero

Alghero, , Italy

Hospital "Cardinal Massaia"

Asti, , Italy

Hospital "Fatebenefratelli"

Benevento, , Italy

Hospital of Bordighera

Bordighera, , Italy

Hospital "San Giovanni di Dio"

Cagliari, , Italy

Hospital "Pugliese-Ciaccio"

Catanzaro, , Italy

Hospital "L.Parodi Delfino"

Colleferro, , Italy

Hospita "San Giovanni di Dio"

Crotone, , Italy

Hospital "E.Profili" of Fabriano

Fabriano, , Italy

Hospital "F. Veneziale"

Isernia, , Italy

Hospital Civile Legnano

Legnano, , Italy

Hospital of Ortona

Ortona, , Italy

Hospital Fatebenefratelli "Buccheri La Ferla"

Palermo, , Italy

Hospital "Sant'Anna"

Reggio Emilia, , Italy

Hospital " Santa Maria Nuova"

Reggio Emilia, , Italy

Hospital "Policlinico Universitario Campus Biomedico"

Rome, , Italy

Hospital "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, , Italy

Hospital of Scandiano

Scandiano, , Italy

Hospital "Paolo Dettori"

Tempio Pausania, , Italy

Hospital "Santa Maria" of Terni

Terni, , Italy

Hospital "San Giovanni Bosco"

Torino, , Italy

Hospital "Jazzolino"

Vibo Valentia, , Italy

Hospital "San Bortolo"

Vicenza, , Italy

Hospital "Santa Maria Maddalena"

Volterra, , Italy

Countries

Italy

Other Identifiers

EudraCT N. 2008-003842-27

Identifier Type: -

Identifier Source: org_study_id