跳至主要内容
临床试验/NCT03517007
NCT03517007已完成不适用

The DETOURS Trial: De-escalating Empiric Treatment: Opting Out of Rx for Selected Patients With Suspected Sepsis - Opt-Out Protocol Trial

Duke University20 个研究点 分布在 1 个国家目标入组 762 人开始时间: 2018年9月12日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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