SIS multicenter study of duration of antibiotics for intraabdominal infection

腹内感染的抗生素治疗的最佳持续时间尚不清楚，并已 被外科感染学会确定为临床研究的高度优先事项。的最终目标是 我们的研究是优化(和缩短)腹内感染的抗生素治疗时间。 在世界各地。需要检验的假设是，四天的腹内感染治疗 将导致类似的结果和更短的疗程相比，基于 在适当的手术或经皮介入治疗的背景下解决生理参数问题。这 建议采用多中心、随机、双盲(直到治疗的第四天)、非劣势临床试验。 将预定四天的抗生素治疗与一天后终止的抗生素治疗进行比较 白细胞计数正常化(11,000/ul)和体温正常化(&lt；38.0℃) 一整天(最多10天的抗生素治疗)在复杂的 用适当的源头控制治疗腹内感染。入选标准包括年龄？16岁， 有能力获得患者或代孕母亲的知情同意，是否存在腹部感染 要求住院任何时间，并通过开腹、腹腔镜或经皮介入治疗， 而且，当地调查员和首席调查员认为有足够的源头控制。1120 患者将被招募，以确保有足够的权力来评估两个手臂的等效性。初级阶段 终点将是失败率，取决于分配的抗生素治疗持续时间(意图治疗 分析)。失败将被定义为需要再次干预(手术或经皮)，手术部位感染， 或在原介入治疗后30天内死亡，为腹内感染。此外，还包括多个 将评估次级终点，包括抗生素治疗的持续时间和感染发生率。 在非腹部和非手术伤口部位，特别是具有抗生素耐药性的病原体。终极的 我们研究的目标是改变世界各地的做法，特别是通过缩短 腹内感染的抗生素治疗，从而减少资源的利用和减少 抗生素耐药病原菌的筛选。

The optimum duration of antibiotic therapy for intraabdominal infection remains unknown and has been identified by the Surgical Infection Society as a high priority for clinical research. The ultimate objective of our research is to optimize (and reduce) the duration of antibiotic therapy for intraabdominal infection throughout the world. The hypothesis to be tested is that four days of therapy for intraabdominal infection will lead to similar outcomes and a shorter duration of therapy when compared to a course based on the resolution of physiologic parameters in the setting of adequate operative or percutaneous intervention. This proposal is for a multicenter, randomized, double-blind (until the fourth day of therapy), non-inferiority clinical trial comparing a predetermined four days of antibiotic therapy to antibiotic therapy terminated one day after normalization of white blood cell count (¿ 11,000/ul) and normalization of systemic temperature (< 38.0¿ C) for one whole calendar day (and a maximum of 10 days of antibiotic therapy) in the setting of complicated intraabdominal infection treated with adequate source control. Inclusion criteria include age ¿ 16 years, ability to obtain informed consent from the patient or surrogate, presence of an intraabdominal infection requiring any duration of hospitalization and managed with open, laparoscopic, or percutaneous intervention, and, adequate source control in the opinion of the local investigator and Principal Investigator. 1,120 patients will be enrolled to ensure adequate power to assess equivalence of the two arms. The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis). Failure will be defined as need for reintervention (surgical or percutaneous), surgical site infection, or death within 30 days of the original intervention for intraabdominal infection. In addition, multiple secondary endpoints will be assessed, including duration of antibiotic therapy and the incidence of infection at non-abdominal and non-surgical wound sites, particularly with antibiotic-resistant pathogens. The ultimate objective of our research is to change practice throughout the world, specifically by shortening the duration of antibiotic therapy for intraabdominal infections and thus decreasing resorurce utilization and decreasing the selection of antibiotic-resistant pathogens.