SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 518
- 试验地点
- 38
- 主要终点
- The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis).
研究概览
简要总结
The major hypothesis to be tested is that the treatment of intraabdominal infections that have been adequately treated operatively or by percutaneous techniques with three to five days of antibiotics will result in outcomes equivalent to the current standard where treatment is carried out until the patient has returned to normal (normal white blood cell count, temperature, and intestinal function), and that patients treated for three to five days will receive fewer days of antibiotics than the control group that has traditionally received seven to 14 days of treatment.
详细描述
Overall, this is a prospective, randomized, single-blinded (analysis), fifteen-center study using intent to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive antibiotics for 3 to 5 days (4 ± 1 days) after the initial surgical or percutaneous intervention or antibiotics until two calendar days after the patient's white blood cell count, systemic temperature, and gastrointestinal function have normalized (maximum of 10 days). The primary endpoint is the composite rate of in-hospital death and/or recurrence of intraabdominal infection and/or occurrence of surgical site (wound) infection. Secondary endpoints include the occurrence of any infection at any site and infection with antibiotic-resistant pathogens. Patient data through the thirty days following the initial intervention or until hospital discharge (whichever is longer) 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 16 at some sites,(≥ 18 at UVA)
- •ability to obtain informed consent from the subject or surrogate
- •Presence of an intraabdominal infection requiring any duration of hospitalization and managed with open, laparoscopic, or percutaneous intervention.
- •A peripheral white blood cell count of > 11,000/mm and/or temperature ≥ 38.0 C with in 24 hours or gastrointestinal dysfunction sufficient to prevent intake of normal diet within 24hrs of initial operative or percutaneous intervention.
- •Adequate source control in the opinion of the local investigator and PI. Source control is defined as any procedure that stops the ongoing contamination of the peritoneal cavity and removes the majority of the contaminated intraperitoneal contents to the extent that no further acute interventions are felt to be necessary.
排除标准
- •age < 16 years at some sites(< 18 at UVA)
- •Inability to obtain consent from the patient, parents, or surrogate
- •Lack of adequate source control in the opinion of the local investigator or overall PI ( Robert Sawyer)
- •High likelihood of death within 72 hours of initial intervention in the opinion of the local investigator or principal investigator
- •Lack of any clinical improvement within 72 hours of initial intervention in the opinion of the local investigator or principal investigator.
- •Planned relaparotomy
- •Perforated gastric ulcer or duodenal ulcer treated within 24hours of the onset of symptoms
- •Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury
- •Non-perforated, non-gangrenous appendicitis or cholecystitis
- •Gangrenous appendicitis or peritonitis without confirmatory cultures or with cultures without bacterial or fungal growth
- •Ischemic or necrotic intestine without perforation and without positive bacterial or fungal cultures
- •Intraabdominal infection associated with active necrotizing pancreatitis
- •Primary (spontaneous) bacterial peritonitis
- •Intraabdominal infection associated with an indwelling continuous ambulatory peritoneal dialysis catheter.
- •Primary skin closure of an open surgical incision in the presence of diffuse, non-localized peritonitis. Laparoscopic port sites ≥ 2cm may be closed
- •Pregnancy
- •Prior enrollment in this study
- •Enrollment in another therapeutic trial
研究组 & 干预措施
1
antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function
干预措施: duration of antibiotics (Other)
2
4 +/- 1 days of antibiotics
干预措施: duration of antibiotics (Other)
结局指标
主要结局
The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis).
时间窗: 30 days
次要结局
- rate of death within 30 days(30 days)
- rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens(30 days)
- duration of hospitalization(30 days)
- Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics(30 days)
- failure rate for microbiologically evaluable patients(30 days)
- rate of need for reintervention in the abdomen(30 days)
- rate of surgical site infection(30 days)
- rate of any subsequent infection at a site other than the abdomen or the surgical site(30 days)
- rate of infection at a non-abdominal, non-surgical site with a resistant organism(30 days)
- rate of Clostridium difficile infection(30 days)
研究者
Robert Sawyer, MD
PI
National Institute of General Medical Sciences (NIGMS)