A Double-Blind, Double-Dummy, Prospective, Randomized Multiple-Site Study of Oral Finafloxacin 300 mg b.i.d. Versus Oral Ciprofloxacin 250 mg b.i.d. in Patients With Lower Uncomplicated UTI (uUTI) With a Treatment Duration of 3 Days
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Bacteriological eradication of the initial pathogen.
研究概览
简要总结
To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.
详细描述
Patients with clinical signs and symptoms of uUTI who have a high probability of the required number of bacteria in their urine, measured by positive test for nitrite and /or leucocyte esterase by means of a dipstick will be enrolled in this study. Only these patients with bacterial count equal or more than 10e5 cfu/mL will be included in the efficacy analysis. At Baseline, patients will be randomly assigned (2:1) to receive Finafloxacin 300 mg or Ciprofloxacin 250 mg, following a double-dummy design, ie Group 1 will receive Finafloxacin tablets + Ciprofloxacin placebo capsule while Group II will receive Ciprofloxacin capsule + Finafloxacin placebo tablets. The treatment will last in total 3 days. The microbiological results will be compared with the baseline microbiology. If the concentration of initial pathogen in the urine is equal or more than 10e3 cfu/mL in the post-therapy culture compared with the baseline , this will define a bacteriological eradication. Microbiological assessment will be performed as well. Evaluation of the bacteria reinfection or relapse will be performed, based on the microbiology results. The status of clinical improvement and cure will be considered additionally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between 18 and 55 years with uUTI.
- •Two of the following sign and symptoms of uUTI: dysuria, frequency, urgency, miction pain, suprapubic pain, gross hematuria, turbid urine or malodorous urine.
- •Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
- •The result of the dipstick should indicate a high probability of the required number of bacteria.
- •Be able to communicate with the study personnel.
- •Has given written consent to participate in the study.
排除标准
- •Female patients having signs and symptoms of upper urinary tract infection (e.g. fever, flank pain) indicating complicated UTI.
- •Male patients
- •History or evidence of other functional or anatomical abnormalities of the urinary tract (e.g. acute pyelonephritis), diabetes mellitus and immunosuppression.
- •Recurrent cystitis with more than 3 episodes in the past 12 months.
- •Clinical symptoms for more than 7 days before Baseline.
- •Psychiatric, neurological or behavior disorders.
- •Clinically significant serious unstable physical illness.
- •Known uncontrolled condition of hypertension or symptomatic hypotension, known ischemic heart disease or history of myocardial infarction (within 12 months prior study enrolment), coronary artery bypass surgery or percutaneous transluminal coronary angioplasty.
- •Existence of any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
- •Antibiotic intake 2 weeks before study enrolment.
- •Failed UTI therapy within 2 months before study inclusion.
- •Expectancy of concomitant administration of antibiotics, sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminium or calcium intake during the course of the study.
- •Clinically abnormal vital signs, ECG findings and safety laboratory results at Baseline.
- •Known hypersensitivity or contraindication to the use of fluoroquinolones.
- •History of tendon lesions or ruptures during quinolone treatment.
- •Any malignant disease or a history of malignant neoplasm other than carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the last 5 years before Baseline.
- •Current diagnosis or history of substance abuse.
- •Exposure to any of the investigational drugs 30 days prior to Baseline.
- •Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study, e.g. oral (stable doses for at least 3 months prior to Baseline) or injectable (stable doses for at least 2 months prior to Baseline) contraceptives, intrauterine devices (for at least 2 months prior Baseline), double-barrier method, contraceptive patch, female sterilization or condoms.
- •The patient, planned to be enrolled is an employee of any involved study investigator or any involved institution including the study sponsor.
- •Inability or lacking motivation to participate in the study.
研究组 & 干预措施
1
Group I: Finafloxacin tablets + Ciprofloxacin placebo capsule
干预措施: Finafloxacin (Drug)
2
Group II: Ciprofloxacin capsule + Finafloxacin placebo tablets
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Bacteriological eradication of the initial pathogen.
时间窗: 4-6 days
次要结局
- Clinical cure: Absence of signs or symptoms of uUTI.(10-14 days)