NCT03366207已完成4 期
Clinical and Microbiologic Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection in Adult Women.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of Subjects With Combined Clinical and Microbiologic Response
研究概览
简要总结
This is a prospective, Phase 4, open label, multi-center study of the clinical and microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infections in adult women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI
- •Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain, gross hematuria
- •A mid-stream urine specimen with:
- •a dipstick analysis positive for nitrite AND
- •a dipstick analysis positive for leukocyte esterase
- •Has given written informed consent to participate in the study.
排除标准
- •Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea and/or vomiting
- •Receipt of prior effective antibacterial drug therapy for uUTI for the presenting illness unless the recovered pathogen demonstrates resistance to initial antibiotic and clinical symptoms persist
- •Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uUTI
- •Patients with ileal loops or urinary stoma
- •Patients with an indwelling urinary catheter in the previous 30 days
- •Patients with paraplegia
- •Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
- •Any history of trauma to the pelvis or urinary tract
- •Patient's urine culture results, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a potential fungal pathogen
- •Patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin
- •Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant
- •Patient is known to have severe neutropenia
- •Patient is known to be pregnant
- •Patients with uncontrolled diabetes mellitus
- •Patients with a known history of myasthenia gravis
- •Patients who require concomitant administration of tizanidine
- •Patients with a history of allergy to quinolones
- •Patient is considered unlikely to survive the study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
研究组 & 干预措施
Ciprofloxacin
Experimental
Ciprofloxacin for the treatment of uncomplicated urinary tract infection
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Number of Subjects With Combined Clinical and Microbiologic Response
时间窗: From start of treatment until assessment of cure, approximately 12 days
Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen
次要结局
- Microbiologic Response(From start of treatment until assessment of cure, approximately 12 days)
研究者
研究点 (1)
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