Prulifloxacin in Chronic Bacterial Prostatitis (CBP)

NCT03201796 | Completed Phase 2

• 2 other identifiers: 027IC132502014-003757-33
• Study Type: interventional
• Target: 168
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Chronic Bacterial Prostatitis

Keywords

Bacterial prostatitis; CBP; Levofloxacin; Prulifloxacin

Outcome Measures

Primary Outcomes (1)

• 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).

  7 days after the EOT

Secondary Outcomes (6)

• Eradication of bacterial growth

  3 months after the EOT

• Eradication of bacterial growth

  6 months after the EOT

• Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)

  Screening - 7 days after the EOT

• Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)

  Screening - 3 months after the EOT

• Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)

  Screening - 6 months after the EOT

Study Arms (2)

Group 1

EXPERIMENTAL

Prulifloxacin 600 mg

Drug: Prulifloxacin 600 mg

Group 2

ACTIVE COMPARATOR

Levofloxacin 500 mg

Drug: Levofloxacin 500mg

Interventions

Prulifloxacin 600 mg DRUG

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.

Also known as: Unidrox®

Group 1

Levofloxacin 500mg DRUG

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.

Also known as: Levoxacin®

Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male between 18 and 50 years of age (limited included) with no limitation of race.
• Patients presenting symptoms of prostatitis for at least 3 months.
• Laboratory evidence of CBP at Visit 0 (Screening), assessed by
• Meares\&Stamey fourglass test and defined as:
• VB3 or EPS specimen containing ≥10\^2 colony-forming units/ml of pathogen/s if the VB2 specimen is sterile; or
• VB3 or EPS specimen containing ≥10\^2 colony-forming units/ml of pathogen/s different from any present in the VB2.
• Medications for chronic prostatitis and/or medications that may affect bladder or prostate function (including but not limited to hormone therapy, anticholinergic or alpha blocker) must be discontinued at least 7 days before study drug intake.
• Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent.

You may not qualify if:

• Known hypersensitivity or allergy to antibacterial fluoroquinolones or to any components of the study medications.
• Pathogen/s resistant to the study drugs at Visit 0 (Screening).
• Suspicion for prostatic cancer, neurogenic bladder, Benign Prostatic Hypertrophy (BPH), bladder neck obstruction or urethral stricture.
• Body Mass Index (BMI) \< 16 kg/m\^2.
• Immunocompromised patients.
• Signs or symptoms or clinical documentation for concurrent infections (including but not limited to sexually transmitted infections) and/or neoplasm.
• Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests at Visit 0 (Screening Visit).
• Significant liver disease, defined as known active hepatitis or elevated liver enzymes \> 3 times the upper boundary of the normal ranges.
• Value of creatinine outside the normal ranges and judged clinically relevant by Investigator.
• History of cardiac disease, including but not limited to myocardial infarction, heart failure, cardiomyopathy, cardiac hypertrophy, cardiac arrhythmias, bradycardia, cardiac conduction abnormalities, long QT syndrome.
• Value of electrolytes (sodium, potassium, calcium, magnesium, chloride) outside the normal ranges and judged clinically relevant by Investigator.
• Patients under treatment with medications that may cause increase of the QT interval.
• History of tendinopathy.
• Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase, or with hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption.
• Recent or past history of psychiatric illness or epilepsy.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Hippocrates Research: collaborator

Study Sites (11)

Urology Clinic General Hospital of Athens "GENNIMATAS"

Athens, 15669, Greece

Location

Urology Department General Hospital of Piraeus "TZANEIO"

Piraeus, 18536, Greece

Location

U.O. di Urologia- Azienda Ospedaliera San Giuseppe Moscati

Avellino, 83100, Italy

Location

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

Bologna, 40138, Italy

Location

Urologia- Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

Catania, 95123, Italy

Location

Clinica Urologica- Azienda Ospedaliero Universitaria Mater Domini

Catanzaro, Italy

Location

Azienda Ospedaliero-Universitaria "Careggi"

Florence, 50134, Italy

Location

Azienda Ospedaliera Universitaria "Federico II"- Dip. Di Ostreticia, ginecologia, Urologia

Napoli, 80131, Italy

Location

Clinica Urologica del Dipartimento di Scienze Chirurgiche- Policlinico Universitario Agostino Gemelli di Roma

Roma, 00168, Italy

Location

S.C. Urologia- AO "Città della Salute e della Scienza" di Torino - OSP.S. GIOV.BATTISTA MOLINETTE

Torino, 10126, Italy

Location

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

Trento, 38123, Italy

Location

Related Links

• Related Info

MeSH Terms

Conditions

Prostatitis

Interventions

prulifloxacin; Levofloxacin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The present study will be performed in double blind condition. Consequently, during the study, neither the Investigator nor the patient will be aware of the treatment assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, levofloxacin controlled, multicentre, international, prospective study.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 28, 2017
• Study Start: February 2, 2016
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (9); GR (2)