DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017