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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
Oral administration of one tablet once daily for 28 days of prulifloxacin 600 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.
Oral administration of one tablet once daily for 28 days of levofloxacin 500 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.
Urology Clinic General Hospital of Athens "GENNIMATAS"
Athens, Greece
Urology Department General Hospital of Piraeus "TZANEIO"
Piraeus, Greece
U.O. di Urologia- Azienda Ospedaliera San Giuseppe Moscati
Eradication of bacterial growth
Eradication defined as absence of bacterial growth as \<10\^2 CFU/ml in voided bladder 3 (VB3) or expressed prostatic secretion (EPS) after 7 days from the End Of Treatment (EOT).
Time frame: 7 days after the EOT
Eradication of bacterial growth
Eradication defined as absence of bacterial growth as \<10\^2 CFU/ml in voided bladder 3 (VB3) or expressed prostatic secretion (EPS) after 3 months from the EOT.
Time frame: 3 months after the EOT
Eradication of bacterial growth
Eradication defined as absence of bacterial growth as \<10\^2 CFU/ml in voided bladder 3 (VB3) or expressed prostatic secretion (EPS) after 6 months from the EOT.
Time frame: 6 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Reduction of total score in NIH-CPSI after 7 days from the EOT in comparison to the screening.
Time frame: Screening - 7 days after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Reduction of total score in NIH-CPSI after 3 months from the EOT in comparison to the screening.
Time frame: Screening - 3 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Reduction of total score in NIH-CPSI after 6 months from the EOT in comparison to the screening.
Time frame: Screening - 6 months after the EOT
Frequency of treatment-related adverse events
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Avellino, Italy
U.O. Dipartimento della Donna, del bambino e delle malattie urologiche - Azienda ospedaliero- Universitaria e Policlinico di Bologna
Bologna, Italy
Urologia- Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
Catania, Italy
Clinica Urologica- Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, Italy
Azienda Ospedaliero-Universitaria "Careggi"
Florence, Italy
Azienda Ospedaliera Universitaria "Federico II"- Dip. Di Ostreticia, ginecologia, Urologia
Napoli, Italy
Clinica Urologica del Dipartimento di Scienze Chirurgiche- Policlinico Universitario Agostino Gemelli di Roma
Roma, Italy
S.C. Urologia- AO "Città della Salute e della Scienza" di Torino - OSP.S. GIOV.BATTISTA MOLINETTE
Torino, Italy
...and 1 more locations
Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses.
Time frame: 6 months