NCT01527019撤回3 期
A Phase III Non-Inferiority Open-label Multicenter Randomized Clinical Trial to Compare CEPHALOSPORIN to NORFLOXACIN in the Treatment of Acute Cystitis
Eurofarma Laboratorios S.A.0 个研究点开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Bacteriological Eradication
研究概览
简要总结
This study is to assess if the efficacy of cephalosporin is similar to the efficacy of norfloxacin in the acute cystitis treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign, initialize and date the informed consent form
- •Age ≥ 18 years
- •For urinary infection diagnosis, the following parameters must be considered in the urine I test:
- •Leukocyturia: ≥ 15,000 leukocytes
- •Epidermal cells: < 20,000/mL
- •Presence of bacteriuria
- •Presence of nitrite (positive results)
- •To have a 2 points score (from 12 points) regarding the following symptoms of acute cystitis:
- •Urinary urgency
- •Frequent urination
- •Pain in the upper area of pubis
- •Each symptom must be scored according to the classification below. Total score may range from 0 to 12 points.
- •Severity Value Absent 0 Mild 1 Moderate 2 Severe 3
排除标准
- •Research subjects that meet any of the criteria below will not be eligible for the study:
- •Asymptomatic urinary infection or infection in any organ
- •Documented incidence of UTI in the last year
- •Symptoms of pyelonephritis (cystitis symptoms plus fever, lower back pain or chills)
- •History of complicated urinary tract infection (congenital abnormalities, urinary tract distortion or obstruction, formation of calculus in the urinary tract)
- •Use of catheter in the urinary tract
- •Chronic renal or hepatic disease
- •Seizure-related diseases
- •Neurological deficits that interfere in the urinary flow and tract defense
- •Decompensated diabetes mellitus (fasting blood glucose ≥ 150 mg/dL);
- •Immunodepression:
- •Subjects with the human immunodeficiency virus (HIV)
- •Chronic use of corticosteroids in a dose ≥ 5 mg/day of prednisone for over 30 days
- •Any diseases related to immune dysfunction
- •Severe comorbidities (at the investigator's discretion)
- •History of allergy to penicillins, cephalosporines or quinolones
- •Subjects on medications such as antibiotics, amiodarone, antacids or sucralphate, tricyclic antidepressants, antipsychotics, cyclosporine, cisapride, didanosine, erythromycin, fembufeno, gliburide (a sulphonilurea), nitrofurantoin, probenecid, procainamide, quinidine, sotalol, teophylline, warfarin
- •Treatment due to UTI two weeks before entering study, or on antimicrobial treatment at least 3 times within the last 12 months
- •Use of phenazopyridine 7 days before entering the study
- •Hospitalization 30 days before study enrollment
- •Female research subjects that are pregnant, breastfeeding, or women with childbearing potential that deny to use at least two safe contraceptive methods during study
- •Participation in another clinical trial in the last 12 months
研究组 & 干预措施
Cephalosporin oral suspension
Experimental
130 research subjects on cephalosporin oral suspension (test) 400 mg once daily
干预措施: Cephalosporins (Drug)
Cephalosporin capsules
Experimental
130 research subjects on cephalosporin capsules (test) 400 mg once daily
干预措施: Cephalosporins (Drug)
Norfloxacin
Active Comparator
130 research subjects on norfloxacin (test) 400 mg twice daily
干预措施: Norfloxacin (Drug)
结局指标
主要结局
Bacteriological Eradication
时间窗: 5-9 days
The primary endpoint of this study will be the bacteriological eradication rate obtained 5-9 days following the end of the treatment with study drugs.
次要结局
- Clinical Cure(bacteriological eradication rate 4-6 weeks; clinical cure rate 5-9 days; clinical cure rate 4-6 weeks;uroculture 5-9 days and 4-6 weeks)
研究者
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