A Prospective, Double-blind, Multi Center, Randomized Clinical Study to Compare the Efficacy and Safety of Ertapenem 3 Days Versus Ampicillin-Sulbactam 3 Days in the Treatment of Localized Community Acquired Intra-abdominal Infection (IAI). (T.E.A. Study Three Days Ertapenem vs Three Days Ampicillin- Sulbactam)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI
研究概览
简要总结
The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.
详细描述
The study project is a prospective, randomized controlled investigation. The study will be performed in the Department of Transplant, General and Emergency Surgery of St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institution, with the participation of all surgeons who accept to be involved in.
The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations.
The tolerability and efficacy of a 3 days treatment with Ampicillin- Sulbactam (AS 3g x 3/ day i.v.) is compared a 3 days regimen with Ertapenem (1 g/day i.v.). in patients with localized peritonitis with a blinded evaluation of efficacy end points. Evaluation of cure or failure is blinded by use of designated third party individuals who are unaware of the treatment assigned to the patients.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity):
- •Acute appendicitis: Ruptured or perforated with abscess
- •Acute diverticulitis with perforation and/or abscess
- •Acute cholecystitis (including gangrenous) with either rupture or perforation
- •Acute gastric and duodenal ( > 24 hours) perforation
- •Traumatic (> 12 hours) perforation of the intestines
- •Secondary peritonitis due to perforated viscus
- •Intra-abdominal abscess (including of liver and spleen)
排除标准
- •Traumatic bowel perforation requiring surgery within 12 hours
- •Perforation of gastroduodenal ulcers requiring surgery within 24 hours
- •other intra-abdominal processes in which the primary etiology was unlikely to be infectious.
- •Patients lactating or pregnant
- •Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics
- •Patients with rapidly progressive or terminal illness;
- •Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2);
- •Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics.
研究组 & 干预措施
E
3 days regimen with Ertapenem
干预措施: Ertapenem (Drug)
AS
3 days treatment with Ampicillin-Sulbactam
干预措施: Ampicillin-Sulbactam (Drug)
结局指标
主要结局
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI
时间窗: 3 days
次要结局
- Any other complication(intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up)
- The total costs of antibiotic therapy(during hospital stay)