Comparison of Two Durations of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in Intensive Care Unit: a Randomised Multicentre Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- The number of antibiotic-free days at D28 after inclusion
研究概览
简要总结
The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days period when compared to conventional (15 days) treatment.
详细描述
This is a prospective randomized study involving 25 centers. Our goal is to demonstrate in the course of postoperative peritonitis that a short antibiotic therapy (8 days) compared to conventional antibiotic treatment (15 days) decreases the duration of exposure to antibiotics over a 28 days period . Patients admitted in ICU, operated for postoperative peritonitis and receiving an adequate antibiotic therapy will be identified and after informed consent is obtained will be randomized to receive a short course of antibiotic therapy (8 days) or a long course of antibiotic therapy (15 days). The primary endpoint is the number of antibiotic-free days at D28 after inclusion (analysis of superiority) . Secondary endpoints include mortality at D45 after inclusion (analysis of equivalence), the occurrence of relapse of infection, success rate of clinically and microbiologically evaluable patients, and emergence of multidrug resistant microorganisms in clinical isolates or hygiene samples. Patient data through day 45 following the initial intervention or until hospital discharge will be tracked.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The eligible patients have to fulfill all the following criteria
- •patients admitted in intensive care unit
- •in the 24 hours following surgery for postoperative intra-abdominal infection (defined as gross pus or purulent effusion within the peritoneal cavity or in one or several collections). Postoperative infection will be defined as an infection observed in a delay of 60 days following a procedure (endoscopy, surgery (abdominal, urologic, gynecologic or vascular surgery or any surgery performed in the peritoneal or retroperitoneal space) or interventional radiology)
- •having peroperative microbiologic samples collected
- •receiving an empiric antibiotic therapy initiated within the first 24 hours after completion of surgery
- •with a written informed consent from the patient or the relative or the legal representative or with an emergency consent
- •Non-inclusion criteria :
- •Patients with one of the following criteria are eligible for the study :
- •Duration of stay following inclusion <72 hours
- •neutropenia (PMN<500/mm3) due to chemotherapy or hematological disease
- •AIDS stage C
- •Immunosuppressive therapy or prolonged steroid therapy (≥0.5 mg/kg/d of prednisone or equivalent >1 month
- •Bowel perforation following endoscopy treated in a delay <6 hours after injury
- •Uterine perforation following a surgical procedure treated in a delay <6 hours after injury
- •Moribund patient (SAPS II score >65 within 12 hours preceding inclusion)
- •Limitation of treatment previously decided
- •Surgery considered as non curative by the surgeon
- •Patient included in another clinical trial evaluating an antimicrobial agent
- •Secondary exclusion criteria:
- •Among the eligible patients, those who have one of the following criteria will be excluded
- •Negative culture of the peritoneal fluid
- •Peritoneal culture exclusively fungal
- •Inadequate empiric antibiotic therapy (not targeting all the microorganisms cultured from peritoneal or blood cultures) within 24 hours after surgery
- •Death between D1 and D8
排除标准
- 未提供
结局指标
主要结局
The number of antibiotic-free days at D28 after inclusion
时间窗: 28 days
The number of antibiotic-free days at D28 after inclusion (analysis of superiority)
次要结局
- Number of days alive without organ failure(28 days)
- Failure rate for clinically evaluable patients(28 days)
- Failure rate for microbiologically evaluable patients(28 days)
- Mortality at D45 after inclusion(45 days)
- Duration of ICU and hospital stay(45 days)
- Evolution of procalcitonin plasma concentration(15 days)
- Changes in SOFA score(8 days)
- Total cost of antibiotic agents(28 days)
- Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration(Hospital discharge)
- Rate of relapse within 45 days(45 days)
- Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples(ICU discharge)
- Rate of death within 45 days in specific subpopulations (elderly patients >80 years ; morbidly obese patients BMI>25kg/m2 ; severe infection with SAPSII score >40 ;peritoneal infection involving pseudomonas or enterococci ; bacteriemic infections)(45 days)