EUCTR2014-003757-33-IT进行中（未招募）不适用
Evaluation of the efficacy and safety of prulifloxacin vs levofloxacin in the treatment of Chronic Bacterial Prostatitis - Prulifloxacin in CBP
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.0 个研究点目标入组 148 人开始时间: 2015年5月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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;
- •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
排除标准
- •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).
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