Prulifloxacin in Chronic Bacterial Prostatitis (CBP)

May 12, 2021 updated by: Aziende Chimiche Riunite Angelini Francesco S.p.A

Evaluation of the Efficacy and Safety of Prulifloxacin vs Levofloxacin in the Treatment of Chronic Bacterial Prostatitis.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 15669
        • Urology Clinic General Hospital of Athens "GENNIMATAS"
      • Piraeus, Greece, 18536
        • Urology Department General Hospital of Piraeus "TZANEIO"
  • Italy
      • Avellino, Italy, 83100
        • U.O. di Urologia- Azienda Ospedaliera San Giuseppe Moscati
      • Bologna, Italy, 40138
        • U.O. Dipartimento della Donna, del bambino e delle malattie urologiche - Azienda ospedaliero- Universitaria e Policlinico di Bologna
      • Catania, Italy, 95123
        • Urologia- Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
      • Catanzaro, Italy
        • Clinica Urologica- Azienda Ospedaliero Universitaria Mater Domini
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-universitaria "Careggi"
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria "Federico II"- Dip. Di Ostreticia, ginecologia, Urologia
      • Roma, Italy, 00168
        • Clinica Urologica del Dipartimento di Scienze Chirurgiche- Policlinico Universitario Agostino Gemelli di Roma
      • Torino, Italy, 10126
        • S.C. Urologia- AO "Città della Salute e della Scienza" di Torino - OSP.S. GIOV.BATTISTA MOLINETTE
      • Trento, Italy, 38123
        • Urologia- Ospedale di Trento- Presidio ospedaliero S. Chiara - Azienda Provinciale per i servizi sanitari (APSS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male between 18 and 50 years of age (limited included) with no limitation of race.
  2. Patients presenting symptoms of prostatitis for at least 3 months.

  3. Laboratory evidence of CBP at Visit 0 (Screening), assessed by

    Meares&Stamey fourglass test and defined as:

    1. VB3 or EPS specimen containing ≥10^2 colony-forming units/ml of pathogen/s if the VB2 specimen is sterile; or
    2. VB3 or EPS specimen containing ≥10^2 colony-forming units/ml of pathogen/s different from any present in the VB2.
  4. 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.
  5. Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent.

Exclusion Criteria:

  1. Known hypersensitivity or allergy to antibacterial fluoroquinolones or to any components of the study medications.
  2. Pathogen/s resistant to the study drugs at Visit 0 (Screening).
  3. Suspicion for prostatic cancer, neurogenic bladder, Benign Prostatic Hypertrophy (BPH), bladder neck obstruction or urethral stricture.
  4. Body Mass Index (BMI) < 16 kg/m^2.
  5. Immunocompromised patients.
  6. Signs or symptoms or clinical documentation for concurrent infections (including but not limited to sexually transmitted infections) and/or neoplasm.
  7. Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests at Visit 0 (Screening Visit).
  8. Significant liver disease, defined as known active hepatitis or elevated liver enzymes > 3 times the upper boundary of the normal ranges.
  9. Value of creatinine outside the normal ranges and judged clinically relevant by Investigator.
  10. 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.
  11. Value of electrolytes (sodium, potassium, calcium, magnesium, chloride) outside the normal ranges and judged clinically relevant by Investigator.
  12. Patients under treatment with medications that may cause increase of the QT interval.
  13. History of tendinopathy.
  14. 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.
  15. Recent or past history of psychiatric illness or epilepsy.
  16. Treatment with antibiotics or antibacterials within 2 weeks before study drug start intake.
  17. Treatment with experimental drugs (prulifloxacin or levofloxacin) or other fluoroquinolones within 4 weeks before study drug start intake.
  18. Diabetic patients in treatment with oral hypoglycemic drugs and insulin.
  19. Patients under treatment with corticosteroids or Non-Steroidal Antiflammatory Drugs (NSAIDs).
  20. Concomitant treatment with xanthines or anticoagulant drugs or drugs producing hypokalemia or diuretics.
  21. Positive history for drugs and alcohol abuse.
  22. Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e. uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study).
  23. Vulnerable subjects (i.e. persons kept in detention).
  24. Subject involved in the conduct of the study (i.e. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).
  25. Participation to an interventional clinical trial within 3 months prior to Visit 0 (Screening Visit).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Prulifloxacin 600 mg
Drug: Prulifloxacin 600 mg
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.
Other Names:
  • Unidrox®
Active Comparator: Group 2
Levofloxacin 500 mg
Drug: Levofloxacin 500mg
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.
Other Names:
  • Levoxacin®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eradication of bacterial growth
Time Frame: 7 days after the EOT
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eradication of bacterial growth
Time Frame: 3 months after the EOT
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.
3 months after the EOT
Eradication of bacterial growth
Time Frame: 6 months after the EOT
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.
6 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Time Frame: Screening - 7 days after the EOT
Reduction of total score in NIH-CPSI after 7 days from the EOT in comparison to the screening.
Screening - 7 days after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Time Frame: Screening - 3 months after the EOT
Reduction of total score in NIH-CPSI after 3 months from the EOT in comparison to the screening.
Screening - 3 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Time Frame: Screening - 6 months after the EOT
Reduction of total score in NIH-CPSI after 6 months from the EOT in comparison to the screening.
Screening - 6 months after the EOT
Frequency of treatment-related adverse events
Time Frame: 6 months
Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aziende Chimiche Riunite Angelini Francesco S.p.A

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hippocrates Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 027IC13250
  • 2014-003757-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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