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Prulifloxacin in Chronic Bacterial Prostatitis (CBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201796
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Hippocrates Research
Information provided by (Responsible Party):
Aziende Chimiche Riunite Angelini Francesco S.p.A

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.

Condition or disease Intervention/treatment Phase
Chronic Bacterial Prostatitis Drug: Prulifloxacin 600 mg Drug: Levofloxacin 500mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, levofloxacin controlled, multicentre, international, prospective study.
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Prulifloxacin vs Levofloxacin in the Treatment of Chronic Bacterial Prostatitis.
Actual Study Start Date : February 2, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: Levoxacin®




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Frequency of treatment-related adverse events [ Time Frame: 6 months ]
    Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201796


Locations
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Greece
Urology Clinic General Hospital of Athens "GENNIMATAS"
Athens, Greece, 15669
Urology Department General Hospital of Piraeus "TZANEIO"
Piraeus, Greece, 18536
Italy
U.O. di Urologia- Azienda Ospedaliera San Giuseppe Moscati
Avellino, Italy, 83100
U.O. Dipartimento della Donna, del bambino e delle malattie urologiche - Azienda ospedaliero- Universitaria e Policlinico di Bologna
Bologna, Italy, 40138
Urologia- Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
Catania, Italy, 95123
Clinica Urologica- Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, Italy
Azienda Ospedaliero-Universitaria "Careggi"
Firenze, Italy, 50134
Azienda Ospedaliera Universitaria "Federico II"- Dip. Di Ostreticia, ginecologia, Urologia
Napoli, Italy, 80131
Clinica Urologica del Dipartimento di Scienze Chirurgiche- Policlinico Universitario Agostino Gemelli di Roma
Roma, Italy, 00168
S.C. Urologia- AO "Città della Salute e della Scienza" di Torino - OSP.S. GIOV.BATTISTA MOLINETTE
Torino, Italy, 10126
Urologia- Ospedale di Trento- Presidio ospedaliero S. Chiara - Azienda Provinciale per i servizi sanitari (APSS)
Trento, Italy, 38123
Sponsors and Collaborators
Aziende Chimiche Riunite Angelini Francesco S.p.A
Hippocrates Research
Additional Information:
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Responsible Party: Aziende Chimiche Riunite Angelini Francesco S.p.A
ClinicalTrials.gov Identifier: NCT03201796    
Other Study ID Numbers: 027IC13250
2014-003757-33 ( EudraCT Number )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aziende Chimiche Riunite Angelini Francesco S.p.A:
Bacterial prostatitis
CBP
Levofloxacin
Prulifloxacin
Additional relevant MeSH terms:
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Prostatitis
Prostatic Diseases
Levofloxacin
Ofloxacin
Prulifloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors