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

COPD Exacerbation Clinical Trial

— FLOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710488
• Other study ID #: EudraCT N. 2008-003842-27
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2012
• Last updated: January 11, 2017
• Start date: May 2009
• Est. completion date: November 2013

Study information

• Verified date: October 2012
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	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 " Santa Maria Nuova"	Reggio Emilia
Italy	Hospital "Sant'Anna"	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

Sponsors (1)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rehospitalization for COPD exacerbation during the follow-up		one year	Yes
Other	Number of episodes of Exacerbations		one year	Yes
Other	Additional cycles of antibiotic		one year	Yes
Other	survival		one year	Yes
Primary	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	Yes
Secondary	Percentage of successful treatment to day 7 of treatment		7 days	Yes