Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 257
- 主要终点
- Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population
研究概览
简要总结
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)
详细描述
This multi-center, retrospective study of cases of serious bacterial infections (including cUTI or AP, HABP, VABP, and/or bacteremia caused by CRE) will consist of a chart review over a 6 month period from September 1, 2013 to March 1, 2014. De-identified data will be collected from the chart review of at least 150 cases of selected infections due to CRE at approximately 20 sites.
The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study.
Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Male or female ≥18 years of age.
- •Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP, VABP, and/or bacteremia.
- •Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia.
排除标准
- 未提供
结局指标
主要结局
Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population
时间窗: 6 month period from September 1, 2013 to March 1, 2014
次要结局
未报告次要终点