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临床试验/NCT04477980
NCT04477980已完成不适用

Retrospective Review on Patients With Culture Negative Empyema

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
1
主要终点
Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)

研究概览

简要总结

Empyema is associated with a wide range of complication and mortality. It is defined by either a positive pleural fluid culture or grossly pus appearance. However, little is known about the differences in aetiology and outcome between culture-positive empyema (CPE) and culture-negative empyema (CNE). The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE.

详细描述

Pneumonia is a common disease and it ranked second as the leading cause of death in Hong Kong in 2016. Among patients suffering from acute pneumonia, up to 57% of them would develop parapneumonic effusion. Without proper treatment, parapneumonic effusion would progress into empyema, which is a clinical emergency. Empyema leads to a longer length of hospital stay, a higher rate of complication and mortality than uncomplicated parapneumonic effusion.

The mainstay of treatment for empyema is antibiotics and drainage. Therefore, identification of causative microorganism is important in guiding the choice of antibiotics. The common bacterial culprits, for community acquired and hospital acquired, were identified by various local and international studies. However, the aetiological agents were still unknown in up to 40% of cases. In addition, the clinical outcomes between culture negative empyema (CNE) and culture positive empyema (CPE) are largely unknown. Data from one Taiwanese study suggested that patients with CPE had a higher in-hospital mortality than those with CNE. However, the primary objective of this study was not putting on the importance of CNE. Therefore, data on outcome of CNE patients remain largely uncertain, either worldwide and local population.

The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE. Through more understanding of CNE, the clinical management of this patient group may be altered and a better patient outcome is anticipated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • i. All patients hospitalized for empyema, defined by the presence of purulent pleural fluid or positive culture result from pleural fluid ii. Age greater than 18 years old

排除标准

  • i. Inappropriate diagnosis of empyema after evaluation ii. Tuberculous pleuritis, defined by presence of Mycobacterium tuberculosis culture from pleural fluid or granulomatous inflammation on pleural biopsy histology

结局指标

主要结局

Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)

时间窗: Within the same episode of hospitalization or 7 days, whichever longer

Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)

次要结局

  • Prevalence of negative pleural fluid culture in patients with empyema(6 years)
  • b. Compare other clinical outcomes (length of hospital stay, duration of intravenous antibiotics, number of pleural drainage received, need of surgical treatment, 30-days and 90-days mortality) between patients with CNE and CPE(Within the same episode of hospitalization or 90 days, whichever longer)
  • Investigate the risk factors of failure to obtain culture results in patients with CNE(Within the same episode of hospitalization or 7 days, whichever longer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ka Pang Chan

Honorary Clinical Tutor

Chinese University of Hong Kong

研究点 (1)

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