Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD
Information source: Fadoi Foundation, Italy
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD Exacerbation
Intervention: Levofloxacin 1 tablet 500 mg once a day (Drug); Prulifloxacin 1 tablet 600 mg once a day (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Fadoi Foundation, Italy Official(s) and/or principal investigator(s): Gualberto GG Gussoni, MD, PhD, Study Director, Affiliation: Dept. Clinical Research "Study Centre" - FadoiFoundation
Overall contact: Antonella AV Valerio, MSc, PhD, Phone: 00390248005140, Email: antonella.valerio@fadoi.org
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)
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: 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).
Secondary outcome: Percentage of successful treatment to day 7 of treatment
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
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Antonella AV Valerio, MSc, PhD, Phone: 00390248005140, Email: antonella.valerio@fadoi.org
Hospita "San Francesco Caracciolo", Agnone 86081, Italy; Recruiting Giovanni Amedeo Di Nucci, MD, Principal Investigator
Hospital of Alghero, Alghero 07041, Italy; Recruiting Francesco Flumene, MD, Principal Investigator
Hospital "Cardinal Massaia", Asti 14100, Italy; Recruiting Valerio Tommaselli, MD, Principal Investigator
Hospital "Fatebenefratelli", Benevento 82100, Italy; Recruiting Francesco Sgambato Francesco Sgambato, MD, Principal Investigator
Hospital of Bordighera, Bordighera 18012, Italy; Recruiting Renato Ariano, MD, Principal Investigator
Hospital "San Giovanni di Dio", Cagliari 09124, Italy; Recruiting Mario Brundu, MD, Principal Investigator
Hospital "Pugliese-Ciaccio", Catanzaro 88100, Italy; Recruiting Vincenzo Cimellaro Vincenzo Cimellaro, MD, Sub-Investigator
Hospital "L.Parodi Delfino", Colleferro 00034, Italy; Recruiting Salvatore Di Simone, MD, Sub-Investigator
Hospita "San Giovanni di Dio", Crotone 88900, Italy; Recruiting Raffaele Costa, MD, Sub-Investigator
Hospital "E.Profili" of Fabriano, Fabriano 60044, Italy; Recruiting Marco Candela, MD, Principal Investigator
Hospital "F. Veneziale", Isernia 86170, Italy; Recruiting Cecilia Politi, MD, Principal Investigator
Hospital Civile Legnano, Legnano 20025, Italy; Recruiting Luca Umberto Pavan, MD, Sub-Investigator
Hospital of Ortona, Ortona 66100, Italy; Recruiting Cinzia Santeusanio, MD, Sub-Investigator
Hospital Fatebenefratelli "Buccheri La Ferla", Palermo 90123, Italy; Recruiting Audenzio D'Andelo, MD, Principal Investigator
Hospital " Santa Maria Nuova", Reggio Emilia 42123, Italy; Recruiting Anna Maria Casali, MD, Sub-Investigator
Hospital "Sant'Anna", Reggio Emilia 42035, Italy; Recruiting Paquale Juri, MD, Sub-Investigator
Hospital "Policlinico Universitario Campus Biomedico", Rome 00128, Italy; Recruiting Sebastiano Costantino, MD, Principal Investigator
Hospital "Casa Sollievo della Sofferenza", San Giovanni Rotondo 71013, Italy; Recruiting Stefano Carughi, MD, Sub-Investigator
Hospital of Scandiano, Scandiano 42019, Italy; Recruiting Alberto Catania, MD, Sub-Investigator
Hospital "Paolo Dettori", Tempio Pausania 0729, Italy; Recruiting Luciano Addis, MD, Principal Investigator
Hospital "Santa Maria" of Terni, Terni 05100, Italy; Recruiting Maurizio Fioretti, MD, Principal Investigator
Hospital "San Giovanni Bosco", Torino 10100, Italy; Recruiting Massimo Giusti, MD, Principal Investigator
Hospital "Jazzolino", Vibo Valentia 89900, Italy; Recruiting Luigi Anastasio, MD, Principal Investigator
Hospital "San Bortolo", Vicenza 36100, Italy; Recruiting Giorgio Vescovo, MD, Principal Investigator
Hospital "Santa Maria Maddalena", Volterra 56048, Italy; Recruiting Alessandro Tafi, MD, Principal Investigator
Additional Information
Starting date: May 2009
Last updated: October 17, 2012
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