ISRCTN88111427已完成3 期
Ibuprofen versus nitrofurantoin for uncomplicated urinary tract infection – a randomised parallel trial study
ational University of Ireland0 个研究点目标入组 460 人开始时间: 2017年5月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. GP- diagnosed urinary tract infection and at least one of the symptoms dysuria, urinary frequency, or urgency with/without low abdominal pain
- •3. Aged 18 years or above
- •4. Able and willing to give written informed consent and to comply with the requirements of this study protocol
- •5. Smartphone ownership
排除标准
- •1. Any sign of a complicated infection, such as loin pain, fever, rigors, malaise, or vomiting
- •2. Pregnancy/breastfeeding child
- •3. Non-use of a highly effective contraceptive measure if the woman is considered of childbearing potential (WOCBP). Contraception methods with low user dependency should be used.
- •4. Diabetes mellitus
- •5. Chronic kidney disease (CKD) defined as estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73m2 or acute kidney injury, defined as any previously documented eGFR <60ml/min/1.73m2
- •6. Disease, anatomical abnormality or previous surgery of kidney or urinary tract
- •7. One or more urinary tract infections within the last four weeks
- •8. Permanent bladder catheter or use of bladder catheter within the last four weeks
- •9. Use of antibiotics within the last two weeks
- •10. Use of other investigational drugs within the last 30 days prior to screening
- •11. Concomitant use of NSAIDs and aspirin
- •12. Previous pyelonephritis
- •13. Acute porphyria Previous adverse reaction or hypersensitivity to ibuprofen, or worsening of asthma when using non-steroidal anti-inflammatory drugs
- •14. Previous adverse reaction to nitrofurantoin or other nitrofurans or fosfomycin
- •15. Current use of proton-pump inhibitor or H2 receptor blocker
- •16. Previous upper gastrointestinal bleed or perforation
- •17. Glucose 6 Phosphate Dehydrogenase deficiency
- •18. Severe heart failure (NYHA Class IV) or hepatic failure
- •19. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •20. Known allergy to azo colouring agents
- •21. Inability to follow instructions or comply with follow-up procedures
- •22. Any other medical condition(s) that may put the participant at risk or influence the study results in the investigator’s opinion or the investigator deems unsuitable for the study
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