TCTR20200408003终止3 期
Antibiotic prophylaxis for patients with asymptomatic urinary tract infection undergoing urodynamic study: a randomized-controlled trial
Faculty of Medicine Research Grant Khon Kaen University0 个研究点目标入组 26 人开始时间: 2020年4月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
研究概览
简要总结
The incidence rate of symptomatic UTI after UDS was significantly higher in patients with no antibiotic prophylaxis (5/13; 38.5%) than those who received antibiotic prophylaxis (0%) (P-value 0.04). The microbiological clearance in the urine at 48 hours after UDS was significantly higher in patients who received an antibiotic prophylaxis (8/11; 72.7%) compared to those without an antibiotic prophylaxis (0/13; 0%) (P-value less than 0.001).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Aged over 18 years
- •2. Patients were admitted for the urodynamic examination
- •3. no signs and symptoms of UTI, defined according to at least one of the following
- •- fever (temperature over 37.8-Celsius degree) with no other apparent causes
- •- onset of dysuria, urgency, frequency
- •- suprapubic or flank pain
- •- increased spasticity
- •- autonomic dysreflexia
- •- malaise, lethargy, or sense of unease
- •4. Evidence of pyuria
- •- urine WBC over 10 cells/HPF or
- •-positive urine leukocyte esterase
- •5. Evidence of significant bacteriuria
- •-bacteria count from urine culture more than 10000 CFU/mL from non-catheter specimens or more than 100 CFU/mL from catheter specimens or positive urine nitrite
- •6. Written informed consent
排除标准
- •1. Pregnancy and breastfeeding
- •2. Received any antibiotics 7 days prior to enrollment
- •3. Known allergy or contraindicated for penicillin, ceftriaxone, or gentamicin
- •4. Immunocompromised state defined as received immunosuppressive agents, prednisolone more than 15 mg/day or equivalent dose, chemotherapy session in the past 1 month, neutropenia (WBC less than 1000 cells/mm3)
- •5. Liver cirrhosis child B or C
- •6. History of urinary stones or bladder outlet obstruction
- •7. History of urosepsis post-UDS
研究者
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