Prospective Randomized Clinical Trial Assessing the Efficacy of a Short Course of Intravenous Amoxicillin Plus Clavulanic Acid Followed by Oral Antibiotic in Patients With Uncomplicated Acute Diverticulitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- failure of treatment
研究概览
简要总结
Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an enormous diversity in clinical practice. The investigators' aim was to demonstrate that uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a short hospital admission.
详细描述
A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment" which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours
- •Exclusion Criteria (prerandomization):
- •immunocompromised patients
- •pregnant women
- •clinical suspicion or CT confirmation of complicated acute diverticulitis
- •Karnofsky performance score less than 50%
- •allergy to penicillin
- •Exclusion Criteria (postrandomization):
- •withdrawal of the trial
- •CT confirmation of complicated acute diverticulitis
- •CT not conforming to acute diverticulitis
- •CT performed 72 hours after the admission
- •adverse reaction to the antibiotic
- •bacteriemia
排除标准
- 未提供
研究组 & 干预措施
Short intravenous amoxicillin plus clavulanic acid
Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days
干预措施: amoxicillin plus clavulanic acid (Drug)
Long intravenous amoxicillin plus clavulanic acid
Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days
干预措施: amoxicillin plus clavulanic acid (Drug)
结局指标
主要结局
failure of treatment
时间窗: the 4th day (group 1) or the 8th day (group 2)
次要结局
- emergency admission or hospital readmission for reasons related to the previous diverticulitis(30 days after discharge)
研究者
Yolanda Ribas
Principal Investigator
Consorci Sanitari de Terrassa