EUCTR2016-001596-75-ES进行中（未招募）1 期
Multicentre controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics
Fundació Parc Taulí0 个研究点开始时间: 2016年8月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age between 18 and 80 years old
- •Patients with acute diverticulitis grade 0 according to the modified Neff classification
- •Absence of acute diverticulitis episode in the previous 3 months
- •No treatment with antibiotics for any reason within the previous 2 weeks
- •Absence of relevant comorbidities
- •Patients giving their informed consent to participate in the study. Adecuate cognitive functions
- •Good family support
- •Good symptom control at emergency room
- •Oral tolerance
- •Immunocompetent patients
- •Maximum, one of the forllowing criteria: SIRS (T >38ºC or <36ºC, L >12000 or <4000/uL, Fc >90bpm, Fr >20rpm) or PCR >15mg/dL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Pregnant or breast feeding women
- •Younguer than 18 years or older than 80 years
- •Patients with acute diverticulitis grade I or more according to the Neff classification
- •Acute diverticulitis episode within the last 3 months
- •Imflammatory Bowel Disease
- •Atibiotic intake in the previous 2 weeks
- •Presence of relevant comorbidities
- •Contraindications or alergy to any of the study treatments (amoxicillin-clavulanic, parecetamol, ibuprofen, omeprazol)
- •Patients unable to give their informed consent freely. Unadequate cognitive function
- •absence of good family support
- •Bad symptom control at emergency room
- •Bad oral tolerance
- •Immunosupression
- •More than one of the following criteria: SIRS (T >38ºC o <36ºC, L >12000 o <4000/uL, Fc >90bpm, Fr >20rpm) o PCR >15mg/dL
研究者
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