Single Center, Randomized, Open Label, Prospective Clinical Trial of BioFire FilmArray Assay for Antimicrobial Treatment of Hospital-acquired or Ventilator-associated Pneumonia in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- The proportion of appropriate/optimal early antibiotic regimen
研究概览
简要总结
Microbiologic diagnosis of pneumonia is often limited by a long turnaround time of cultures. This randomized trial aims to evaluate the impact of BioFire FilmArray Pneumonia panel on (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics in patients treated for hospital-acquired or ventilator-associated pneumonia (HAP/VAP) in ICU.
详细描述
The study subjects are adults treated for HAP/VAP in ICU, who should be enrolled within 24 hrs since the first administration of antibiotics. Informed consent are obtained from the subjects or their legal proxies. Due to the unique characteristics of ICU and the current COVID-19 pandemic, consent may be obtained via telephone when given by legal proxies; written consent should be obtained later. The subjects who meet the inclusion criteria are randomized into either intervention and control arms in 1:1 ratio. Respiratory specimens from the subjects in the intervention arm are tested with the FilmArray Pneumonia panel. Other routine microbiologic tests are performed for the subjects in both arms. The results are reported via electronic medical record, and the treating physicians may adjust antibiotic regimen with the assistance from the guidance formulated by the study investigators. No intervention is made on the antimicrobial treatment in the control arm. Primary outcomes are (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 years or older
- •Diagnosed with hospital-acquired or ventilator-associated pneumonia and being treated in an intensive care unit
- •Patient or his/her legal proxy agrees to participate and is able to provide informed consent
排除标准
- •Has been treated with antibiotic for HAP/VAP for 24 hr or longer
- •Requires antibiotic treatment for indications other than HAP/VAP
- •Bacteria has been isolated from respiratory specimens within 7 days prior to screening
- •Immunocompromised host whose major differential diagnosis includes Pneumocystis jirovecii or cytomegalovirus pneumonia
- •Expected to die within 2 days since screening due to underlying disease
- •Has an advance directive against mechanical ventilation or cardiopulmonary resuscitation
- •Does not want to participate or unable to provide consent
- •Determined to be unfit by the study investigator
结局指标
主要结局
The proportion of appropriate/optimal early antibiotic regimen
时间窗: within 24 hours
* "Appropriate" antibiotics: agents active in vitro * "Optimal" antibiotics: appropriate AND not overly broad. Spectrums of antibiotics are categorized with the following hierarchy: colistin \> carbapenem \> piperacillin-tazobactam/4th generation cephalosporins \> other beta-lactams/fluoroquinolones; for gram-positives, glycopeptides/linezolid \> no glycopeptides/linezolid) * Early antibiotic regimen is defined as antibiotics administered ≤24 hr since the initiation of antibiotic treatment
The time to the administration of appropriate antibiotics
时间窗: within 30 days
time interval between the first dose of antibiotics and the first dose of antibiotics confirmed active in vitro
次要结局
- Dialysis-free day(within 30 days)
- ICU mortality(within 30 days)
- Incidence of Clostridioides difficile infection(within 30 days)
- 30-day mortality (all-cause)(within 30 days)
- Hospital and ICU length of stay(Through study completion, an average of 9 months)
- Ventilator-free day(within 30 days)
- Total medical cost in the ICU(within 30 days)
- Duration of antibiotic treatment(within 30 days)
- Incidence of acute kidney injury(within 30 days)
- Acquisition of multi-drug resistance organism during hospital stay(within 30 days)
- Compliance to FilmArray guidance (intervention arm only)(within 30 days)
研究者
Kyungmin Huh
Assistant Professor
Samsung Medical Center