The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 762
- 试验地点
- 20
- 主要终点
- Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection
研究概览
简要总结
The objective of this study is to implement an opt-out protocol to guide appropriate de-escalation of antibiotics in qualifying patients. The protocol, determined over the course a year with the help of a large, well-rounded expert panel, will be used by pharmacists to recommend de-escalation of antibiotics to hospital providers. Providers can then decide whether or not to follow the recommendation in determining the best treatment pathway for his or her patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Blood culture preliminary results that indicate no growth as of 48-96 hours. (Exception: Patients with a single positive blood culture for coagulase negative Staphylococcus and no central line in place will also be included).
- •Still on broad spectrum antibiotic therapy after 48-96 hours.
排除标准
- •Adult patients who are located in ICU wards.
结局指标
主要结局
Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection
时间窗: 30 days post-randomization
Overall inpatient plus post-discharge antibacterial Days of Therapy (DOT) as measured by data collection
次要结局
- Days of therapy for specific sub-groups of patients, including patients whose physicians elected to opt-out of the intervention(30 days post-randomization)
- Negative outcomes as measured by individual clinical outcome components in the DOOR(30 days post-randomization)
- Negative outcomes as measured by number of days patient has a central line(30 days post-randomization)
- percent of eligible patients with antibiotic de-escalation(5 days from initial date of suspected sepsis)
- Negative outcomes as measured by re-initiation of antibiotic therapy after greater than 48 hours with no antibiotics(30 days post-randomization)
- prescriber type(within 3 days (96 hours) of initial date of suspected sepsis)
- prescribers' reported rationale for opting out(within 3 days (96 hours) of initial date of suspected sepsis)
- Distributions of DOOR(up to 2 years)
- number of eligible patients in whom the prescriber chose to opt-out(within 3 days (96 hours) of initial date of suspected sepsis)
- Percent of subjects who received an infectious disease consultation after implementation of the Opt-Out Protocol(30 days post-randomization)
- Negative outcomes as measured by length of hospital stay(30 days post-randomization)
- Number of patients in whom the safety screen was applied(within 3 days (96 hours) of initial date of suspected sepsis)
- Number of patients the safety screen excluded from the opt-out procedure(within 3 days (96 hours) of initial date of suspected sepsis)
- number of eligible patients in whom the opt-out procedure was applied(within 3 days (96 hours) of initial date of suspected sepsis)
