Clinical Impact of a Multiplex Rapid Diagnostic Pneumonia Panel Testing in Critically-ill Patients with Severe Hospital-acquired Pneumonia, Ventilator-associated Pneumonia and Community-acquired Pneumonia with High Risk of Multidrug Resistant Pathogen
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Therapeutic decision [Time Frame: 24 hours following the FilmArray results]
研究概览
简要总结
The objective of the research is to ascertain the influence of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalised in the ICU for severe respiratory disease.
The diagnostic process for pneumonia has become significantly more intricate over the past decade due to the interference of the biological, radiological, and clinical criteria of patients hospitalised in the intensive care unit with the conventional criteria for the diagnosis of severe respiratory diseases. Additionally, patients who are hospitalised in the ICU are at a heightened risk of contracting other associated infections. Consequently, patients are frequently administered antibiotics, whether or not they are effective, as it is challenging to promptly determine the aetiology of their symptoms using conventional methods.
To enhance the diagnostic and therapeutic aspects of their treatment, we implemented a novel syndromic molecular test in our laboratories. This test is designed to expedite and enhance the management of pneumonia and the stewardship of antibiotics. This research will include 80 to 100 adult patients hospitalized in ICU between Feb 2025 and Feb 2027. It will take place within the Siriraj Hospital, Bangkok, Thailand.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients who have received complete information about the research and who have not objected to the use of its data
- •Patients with suspected pneumonia infection
排除标准
- •Patients with following conditions;
- •Active immediate life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation
- •Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage Acute coronary syndrome
- •Cardiogenic shock
- •Life-threatening gastrointestinal hemorrhage
- •Drug overdose
- •Advanced-stage cancer with predicted survival less than 1 year
研究组 & 干预措施
No Intervention: Standard of care
Standard practice
Experimental: Pneumonia panel group
Pneumonia panel measurement and changing of antimicrobials according to the result of pneumonia panel
干预措施: Pneumonia Panel by FilmArray (Diagnostic Test)
结局指标
主要结局
Therapeutic decision [Time Frame: 24 hours following the FilmArray results]
时间窗: 24 hours following the FilmArray results
Antibiotic prescription modification following the FilmArray results as: No prescription No change in antibiotic utilization Antibiotic initiation Antibiotic escalation Antibiotic de-escalation Antibiotic discontinuation
次要结局
未报告次要终点
研究者
Adhiratha Boonyasiri
Assistant professor doctor
Mahidol University