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
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