MDRO: Study of Highly Resistant Escherichia Coli
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Number of participants who received oral step-down therapy
研究概览
简要总结
This is a prospective, observational, multicenter, case-control study.
详细描述
This is an observational cohort study. A total of 300 subjects will be enrolled. Cases are defined as unique subjects who have a monomicrobial blood culture positive for growth of 3rd Generation Cephalosporin Resistant Escherichia coli (3GCR-Ec), defined as resistance to ceftriaxone or cefotaxime, during hospitalization. For each case, the next available unique subject from the same study site, with a monomicrobial blood culture positive for growth of 3rd Generation Cephalosporin Sensitive Escherichia coli (3GCS-Ec) during hospitalization will be included as a control. A waiver of informed consent and HIPAA will be requested. This is a minimal risk study without any direct subject contact. In addition, no subject information will be collected that is not part of routine clinical care.
The trigger for enrollment in the study will be the identification in a participating local microbiology laboratory of a 3GCR-Ec in a monomicrobial blood culture. These will be reported to study personnel at the study site, who will evaluate eligibility. If the subject is deemed eligible, the 3GCR-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate also saved at the local laboratory. Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study. The local microbiology laboratory, or designee, will then identify the next subject available with a 3GCS-Ec in a blood culture. These will also be reported to study personnel for evaluation of eligibility as a control. If the control subject is eligible, the corresponding 3GCS-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate will also be saved at the local laboratory . Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study.
For cases and controls, clinical data will be collected from the electronic health records (EHR) for up to 30 days after the index blood culture. Data collection will be performed by study personnel at the site into a central, secure, research database.
One E. coli isolate per study subject will be collected from the index blood culture. No other biologic samples will be collected. Data will be entered at or after the 30-day time point. There will be no long-term follow-up for subjects.
Primary Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants who received oral step-down therapy
时间窗: Within 30 days of culture collection
Number of participants who received oral-step down therapy for treatment of e. Coli
次要结局
- Duration of antibiotics(From culture collection to 30 days post culture collection)
- Number of participants with resolution or improvement of symptoms(30 days post culture collection)
- Days to discharge(culture collection through 30 days post culture collection)
- Number of participants with a three-fold or greater increase in serum creatinine from day of index culture(culture collection through 30 days post culture collection)
- Number of participants with a Clostridioides difficile infection(culture collection through 30 days post culture collection)
- Number of participants with anatomic source specific symptomatic response(30 days post culture collection)
- Length of stay(hospital admission through 30 days post culture collection)
- Number of participants with ongoing antibiotic treatment at 30 days(30 days post culture collection)
- Duration of intravenous antibiotics(From culture collection to 30 days post culture collection)
- Duration of oral antibiotics(From culture collection to 30 days post culture collection)
- Number of participants who received short course antibiotic therapy(From culture collection to 30 days post culture collection)
- Discharged by 30 days(culture collection through 30 days post culture collection)
- Number of participants with a new positive blood culture with E. coli within 30 days of index culture(culture collection through 30 days post culture collection)
- Number of participants in the ICU on day 0, 3, 5, and 7(Days 0, 3, 5, 7)
- Number of participants with a readmission within 30 days of index culture(culture collection through 30 days post culture collection)
- Number of participants with a newly required renal replacement therapy post index culture(culture collection through 30 days post culture collection)
- Mortality at 30 days(culture collection through 30 days post culture collection)
- Desireability of Outcome Ranking (DOOR) outcome at 30 days(30 days post culture collection)