NCT00097734Unknown4 期
A Prospective, Multicenter, Open-Label, Randomized Clinical Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
Klinikum Hanover-Siloah Hospital2 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2004年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Clinical therapeutic success (full regression)
研究概览
简要总结
The purpose of this study is to compare the efficacy (by assessing the clinical success of treatment) of intravenous antibiotic therapy with ertapenem in patients with acute attacks of sigmoid diverticulitis for 4 vs. 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Educational Counseling Training
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least three of the following signs or symptoms of an acute attack of sigmoid diverticulitis must be present: *Fever (body temperature > 38°C, sublingual), *Abdominal tenderness, *Leukocytosis (leukocytes > 10,000/µl) and left shift of the differential blood count (>1% band forms), *Elevated CRP (> 20 mg/l)
- •Evidence of sigmoid diverticulitis by contrast enema
- •CT evidence of wall thickening in the sigmoid intestine
- •Decision in favor of conservative therapy on the basis of the case history and diagnosis
排除标准
- •Contraindication for the use of the study medication or other beta-lactam antibiotics, e.g. patients with advanced renal impairment or patients requiring hemodialysis
- •Antibiotic therapy in the two weeks prior to the start of the study
- •Patients with an advanced incurable disease
- •Patients with a hematologic/oncologic disease (leukemia, lymphoma)
- •Patients on immunosuppressants
- •Complications of sigmoid diverticulitis leading to an immediate indication for surgery
- •Patients who have hypersensitivity to beta-lactam antibiotics
- •Female patients who are pregnant or nursing or who could become pregnant during the study
- •Participation in another clinical study or use of another study drug within the four weeks prior to enrollment in the study or use of another drug during the study
- •Each patient can be enrolled only once in the study
结局指标
主要结局
Clinical therapeutic success (full regression)
Relapse rate
Operation rate
次要结局
- Development of laboratory parameters
- Duration of hospitalization
- Duration of parenteral feeding
- Incidence of surgical intervention and repeat surgery
- Incidence and duration of intensive care
研究者
研究点 (2)
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