Efficacy and safety of prulifloxacin in Chronic Bacterial Prostatitis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 148

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 four-glass test and defined as:
a. VB3 or EPS specimen containing =100 colony-forming units/ml of pathogen/s if the VB2 specimen is sterile;
or
b. VB3 or EPS specimen containing =100 colony-forming units/ml of pathogen/s that is 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known hypersensitivity or allergy to antibacterial fluoroquinolones and 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/m2.
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 intake.
17. Treatment with experimental drugs (prulifloxacin or levofloxacin) or other fluoroquinolones within 4 weeks before study drug 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 & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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