NCT02650518Unknown2 期
Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections (CARCUTI)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Resolution
研究概览
简要总结
Hypothesis: A short course (3-5 days) of antibiotic therapy (experimental arm) is as safe and effective as a long course of antibiotic therapy for the treatment of catheter-associated urinary tract infections.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients ≥ 21 years old.
- •Presence of indwelling urinary catheter at the time of urine culture for ≥2days.
- •Fever >38°C.
- •A urine specimen sent to the hospital microbiological laboratory for culture.
- •An antibiotic order for presumed symptomatic catheter associated urinary tract infection.
排除标准
- •Persistent fever >38°C for more than 24 hours, or any fever >38.9°C.
- •Haemodynamic instability, defined as:
- •Requirement for intravenous vasopressor agents
- •Systolic blood pressure <90 mmHg
- •Acute hypotensive event with drop in systolic blood pressure of >30 mmHg or diastolic blood pressure of >20 mmHg
- •The following laboratory values within the previous 48 hours (if available):
- •White blood cell count>15 or <4 x10^9/L.
- •Procalcitonin>0.25ug/mL
- •C Reactive Protein >100mg/mL
- •An increase in the serum creatinine of more than 50% from baseline
- •New requirement for oxygen supplement.
- •Current admission to a high dependency unit or ICU.
- •Radiological evidence of an upper urinary tract infection
- •Flank pain or tenderness, suggesting an upper urinary tract infection
- •Urologic surgical procedure within the previous 72 hours
- •Known structural genitourinary abnormalities including:
- •Nephrostomy tubes
- •Tumours of the urinary tract
- •Ureteric stenting
- •Ureteric strictures
- •Urolithiasis
- •Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.
- •Received antibiotics for more than 48 hours prior to randomization.
- •Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.
- •Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.
研究组 & 干预措施
Control
No Intervention
Subject receives the standard of care that is provided by the primary team taking up his/her case.
Catheter change+Short-course Antibiotics
Experimental
干预措施: Short-course Antibiotics (Other)
Catheter change+Short-course Antibiotics
Experimental
干预措施: Catheter Change (Device)
结局指标
主要结局
Resolution
时间窗: Day 14 post-randomisation
Resolution of signs and symptoms of CAUTI
次要结局
- Secondary Infections(3 months post-randomization)
- Recurrent Urinary Tract Infections(3 months and 1 year post-randomization)
- Urologic surgery or procedure(1 year post-randomization)
- Antimicrobial use and duration(1 month post-randomization)
- Colonization or infection by antibiotic-resistant organisms(30 days post-randomization)
- Short-Term Resolution(day 3 and day 7 post-randomisation)
- Recurrence of fever or symptoms(7, 14 and 30 days post randomization)
- Haemodynamic instability(day 14 post randomization)
- Length of hospitalization(30 days post-randomization)
- Re-admission(Day 30 post-randomization)
- Admission to high dependency or intensive care units(14 days post-randomization)
研究者
研究点 (3)
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