Clinical trial NCT01710488: Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD Exacerbation
Keywords: COPD exacerbation
fluoroquinolones,
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 258
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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).
timeFrame: 10 days
Secondary outcomes:
measure: Percentage of Successful Treatment to Day 7 of Treatment
timeFrame: 7 days
Other outcomes:
measure: Rehospitalization for COPD Exacerbation During the Follow-up
timeFrame: one year
measure: Number of Episodes of Exacerbations
timeFrame: one year
measure: Additional Cycles of Antibiotic
timeFrame: one year
measure: Survival
timeFrame: one year
Locations:
city: Agnone
country: Italy
facility: Hospita "San Francesco Caracciolo"
city: Alghero
country: Italy
facility: Hospital of Alghero
city: Asti
country: Italy
facility: Hospital "Cardinal Massaia"
city: Benevento
country: Italy
facility: Hospital "Fatebenefratelli"
city: Bordighera
country: Italy
facility: Hospital of Bordighera
city: Cagliari
country: Italy
facility: Hospital "San Giovanni di Dio"
city: Catanzaro
country: Italy
facility: Hospital "Pugliese-Ciaccio"
city: Colleferro
country: Italy
facility: Hospital "L.Parodi Delfino"
city: Crotone
country: Italy
facility: Hospita "San Giovanni di Dio"
city: Fabriano
country: Italy
facility: Hospital "E.Profili" of Fabriano
city: Isernia
country: Italy
facility: Hospital "F. Veneziale"
city: Legnano
country: Italy
facility: Hospital Civile Legnano
city: Ortona
country: Italy
facility: Hospital of Ortona
city: Palermo
country: Italy
facility: Hospital Fatebenefratelli "Buccheri La Ferla"
city: Reggio Emilia
country: Italy
facility: Hospital "Sant'Anna"
city: Reggio Emilia
country: Italy
facility: Hospital " Santa Maria Nuova"
city: Rome
country: Italy
facility: Hospital "Policlinico Universitario Campus Biomedico"
city: San Giovanni Rotondo
country: Italy
facility: Hospital "Casa Sollievo della Sofferenza"
city: Scandiano
country: Italy
facility: Hospital of Scandiano
city: Tempio Pausania
country: Italy
facility: Hospital "Paolo Dettori"
city: Terni
country: Italy
facility: Hospital "Santa Maria" of Terni
city: Torino
country: Italy
facility: Hospital "San Giovanni Bosco"
city: Vibo Valentia
country: Italy
facility: Hospital "Jazzolino"
city: Vicenza
country: Italy
facility: Hospital "San Bortolo"
city: Volterra
country: Italy
facility: Hospital "Santa Maria Maddalena"
Study officials:
affiliation: Dept. Clinical Research "Study Centre" - FadoiFoundation
name: Gualberto GG Gussoni, MD, PhD
role: STUDY_DIRECTOR
References: