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
相似试验
进行中(未招募)
1 期
Adaptive trial in severe pneumonia Coronavirus COVID-19 (REMAP-CAP-COVID-19)EUCTR2015-002340-14-FRniversity Medical Center Utrecht4,000
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaCOVID-19MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsEUCTR2015-002340-14-NLniversity Medical Center Utrecht20,000
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862EUCTR2015-002340-14-FIniversity Medical Center Utrecht4,000
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaCOVID-19InfluenzaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsEUCTR2015-002340-14-DEniversity Medical Center Utrecht8,000
进行中(未招募)
1 期
Adaptive trial in severe pneumonia (REMAP-CAP)Severe Community Acquired PneumoniaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862EUCTR2015-002340-14-ESniversity Medical Center Utrecht4,000
