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临床试验/NL-OMON53023
NL-OMON53023招募中4 期

Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) - REMAP-CAP

niversitair Medisch Centrum Utrecht0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
1,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • General REMAP-CAP:
  • 1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of
  • hospital admission with
  • a. symptoms or signs or both that are consistent with lower respiratory tract
  • infection AND
  • b. Radiological evidence of new onset infiltrate of infective origin (in
  • patients with pre-existing radiological changes, evidence of new infiltrate)
  • 2. Up to 48 hours after ICU admission, receiving organ support with one or more
  • a. Non-invasive or invasive ventilatory support;
  • b. Receiving infusion of vasopressor or inotropes or both
  • For the COVID-19 domains:
  • 1. COVID-19 infection is suspected by the treating clinician or has been
  • confirmed by microbiological testing (i.e. PISOP stratum)
  • 2. Microbiological testing for SARS-CoV-2 infection of upper or lower
  • respiratory tract secretions or both has occurred or is intended to occur
  • If applicable, domain and/or intervention-specific inclusion criteria listed in

排除标准

  • General REMAP-CAP Exclusion Criteria:
  • 1. Healthcare-associated pneumonia:
  • a. Prior to this illness, is known to have been an inpatient in any
  • healthcare facility within the last 30 days
  • b. Resident of a nursing home or long-term care facility.
  • 2. Death is deemed to be imminent and inevitable during the next 24
  • hours AND one or more of the patient, substitute decision maker or
  • attending physician are not committed to full active treatment.
  • 3. Previous participation in this REMAP within the last 90 days
  • For subjects suspected or proven to have COVID-19, the 48 hour time window does
  • not apply, due to the nature of the disease process.
  • There are specific exclusion criteria (if needed) for every domain or
  • intervention within a domain in the trial, listed in each DSA.

研究者

发起方
niversitair Medisch Centrum Utrecht

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