Last updated on February 2018

Prulifloxacin in Chronic Bacterial Prostatitis (CBP)

Brief description of study

The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to levofloxacin in the treatment of patients affected by CBP.

Detailed Study Description

This is a randomized, double-blind, levofloxacin controlled, parallel group, multicentre, international, prospective study. The patients will be enrolled in the study and will be randomized to prulifloxacin or levofloxacin. Patient enrolment will be competitive.

The present study is planned to verify the microbiological and the clinical efficacy of a 28-day treatment period with prulifloxacin 600 mg in comparison with 28-day treatment period with levofloxacin 500 mg, both administered once daily, in patients with CBP. Safety and tolerability of a 28-day treatment period with prulifloxacin 600 mg will be also evaluated in comparison to levofloxacin 500 mg.

Levofloxacin 500 mg tablets has been selected as treatment comparator because it represents the drug of choice authorised for the treatment of CBP. Consequently, the dosage regimen to be administered to the patients is consistent with that reported in the relevant SPC.

Clinical Study Identifier: NCT03201796

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Ioannis Gkialas, MD

Urology Clinic General Hospital of Athens "GENNIMATAS"
Athens, Greece
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Konstantinos Stamatiou, MD

Urology Department General Hospital of Piraeus "TZANEIO"
Piraeus, Greece
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Virgilio Cicalese, MD

U.O. di Urologia- Azienda Ospedaliera San Giuseppe Moscati
Avellino, Italy
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Eugenio Brunocilla, MD

U.O. Dipartimento della Donna, del bambino e delle malattie urologiche - Azienda ospedaliero- Universitaria e Policlinico di Bologna
Bologna, Italy
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Giuseppe Morgia, MD

Urologia- Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
Catania, Italy
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Rocco Damiano, MD

Clinica Urologica- Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, Italy
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Marco Carini, MD

Azienda Ospedaliero-Universitaria "Careggi"
Firenze, Italy
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Vincenzo Mirone, MD

Azienda Ospedaliera Universitaria "Federico II"- Dip. Di Ostreticia, ginecologia, Urologia
Napoli, Italy
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Emilio Sacco, MD

Clinica Urologica del Dipartimento di Scienze Chirurgiche- Policlinico Universitario Agostino Gemelli di Roma
Roma, Italy
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Paolo Gontero

S.C. Urologia- AO "Citt della Salute e della Scienza" di Torino - OSP.S. GIOV.BATTISTA MOLINETTE
Torino, Italy
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Tommaso Cai, MD

Urologia- Ospedale di Trento- Presidio ospedaliero S. Chiara - Azienda Provinciale per i servizi sanitari (APSS)
Trento, Italy
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