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临床试验/NCT07226557
NCT07226557进行中(未招募)不适用

Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

This study aims to compare 28-day mortality among patients with carbapenem resistant A. baumannii infections in two hypothetical target trials where patients receive 7 days of a cefiderocol-based treatment strategy or 7 days of a best available therapy treatment strategy.

详细描述

please see uploaded study protocol

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized adults (≥ 18 years of age)
  • Carbapenem resistant A. baumannii-calcoaceticus complex clinical culture
  • Antimicrobial agent with possible in vitro activity against carbapenem resistant A. baumannii-calcoaceticus complex initiated in the time frame of 2 days before culture collection until 2 days following first available antibiotic susceptibility test result being made available

排除标准

  • Patients with no antibiotic susceptibility testing
  • Patients with only A. baumannii infection diagnosed by rapid diagnostic tests (i.e., multiplex polymerase chain reaction)
  • Initiation of antimicrobial agent outside of selected time frame (i.e., 2 days before culture collection until 2 days after first available antibiotic susceptibility test result was made available)

结局指标

主要结局

Mortality

时间窗: During inpatient admission

In hospital mortality or discharge to hospice during the hospital stay

次要结局

  • Length of Stay(Inpatient admission)
  • Recurrent CRAB Infection(Within 30 days post discharge)
  • Development of antibiotic resistance to initial antibiotic treatment(Subsequent admissions)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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