Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Narrow-spectrum Antibiotic Treatment
研究概览
简要总结
The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (SCAP). We hypothesize that when results from a rapid diagnostic test (RDT) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events.
详细描述
The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (SCAP). We hypothesize that when results from a rapid diagnostic test (RDT) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the MICU Service
- •Meets one of the following:
- •Have or plan to obtain a bronchoalveolar lavage (BAL)
- •Have or plan to obtain a quantitative endotracheal aspirate sample
- •Have already produced a high-quality sputum sample if not intubated
- •Primary MICU attending and fellow willing to base antibiotic therapy on results of RDT
排除标准
- •Subjects with confirmed extrapulmonary infection requiring antibiotics outside the usual treatment for SCAP, with the exception of suspected uncomplicated urinary tract infection
- •Neutropenic fever, defined as absolute neutrophil count <1000/mm3 and absence of infiltrate on available chest imaging
- •Chronic airway infection, defined as cystic fibrosis, lung transplant, or non-CF bronchiectasis
- •Patient/surrogate refusal
- •Inability to perform BAL, NBBAL, quantitative ETA, or produce a high-quality sputum sample prior to 48 hours from hospital admission
研究组 & 干预措施
Control
Critically ill patients with pneumonia will be treated with an antibiotic strategy at the discretion of the treating clinician
Interventional
Critically ill patients with pneumonia will be treated with an antibiotic strategy based on results from the BioFire Pneumonia Panel
干预措施: BioFire Pneumonia Panel (Diagnostic Test)
结局指标
主要结局
Narrow-spectrum Antibiotic Treatment
时间窗: 14 days
A quantitative tool that reflects how broad or narrow antibiotic is
次要结局
未报告次要终点
研究者
Richard Wunderink
Professor of Medicine, Pulmonary and Critical Care
Northwestern University