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临床试验/NCT03200275
NCT03200275已完成不适用

The Impact of Legionella Urine Antigen Testing (LUAT) on the Local Epidemiology and Diagnosis of Legionella Pneumonia - A Hospital Based Study in Malaysia

Ministry of Health, Malaysia1 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2017年9月12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
505
试验地点
1
主要终点
Legionella Pneumonia

研究概览

简要总结

There has never been a paper published or research done to determine the rate of Legionella species as a cause of community or nosocomial acquired pneumonia requiring hospitalization in Malaysia. Anecdotally, Legionnaires' disease is thought to be uncommon in Malaysia. This is one of the first prospective hospital-based studies to comprehensively evaluate the epidemiological and demographical factors of patients hospitalized with Legionella infection in Malaysia.

详细描述

Legionellosis is an environment-related, acute gram negative bacterial respiratory infection and is caused primarily by the species Legionella pneumophila, an atypical pulmonary pathogen, in the likes of mycoplasma and chlamydia species. Potentially all Legionella spp. may cause human disease, however, the majority (92%) of clinical cases are caused by L. pneumophila and the predominant serogroup is serogroup 1.

Globally, 1-5% of community acquired pneumonia patients is caused by Legionella spp. and is a challenge to public health authorities. The incidence of Legionella Pneumonia in the US has exceeded expectations and is increasing, with at least 13,000 cases occurring annually. In Singapore, Legionella spp. is responsible for 2-7% of cases of hospitalized community-acquired pneumonia.

Legionella pneumophila is being increasingly recognized as a common pathogen causing both community-acquired and nosocomial pneumonia that is responsible for significant morbidity and mortality. It is also one of the most common aetiology discovered when pneumonia is sufficiently severe to require admission to an intensive care unit. It's likely to cause a severe form of pneumonia with high likelihood of adverse medical outcomes which includes rapid deterioration, respiratory failure and the need for intensive care unit (ICU) admission.

It will be impossible to distinguish patients with Legionnaires' disease from patients with other types of pneumonia clinically. The key to diagnosis is to perform microbiologic testing when a patient is stratified into a high-risk category. Rapid diagnosis of these pneumonias is desired as delayed diagnosis and institution of appropriate antibiotics is associated with poor outcomes.

In routine clinical practice, legionellosis is rarely proven by culture whereas detection of urinary antigen is now common. In US and Europe, case detection rates were revolutionized with the usage of urine antigen test at 97% and 79% respectively. Urine antigen testing has a reported sensitivity that ranges between 76% and 86% for cases of Legionella pneumonia serogroup 1 and a specificity that approaches 100%.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • More than 18 years of age,
  • Hospitalized consecutively for pneumonia irrespective of it being community or hospital acquired.
  • Acute symptoms of less than 2 weeks and radiological features which are compatible to pneumonia.

排除标准

  • Under 18 years of age
  • Suspected/confirmed case of active tuberculosis
  • Patients who refused to give consent -

结局指标

主要结局

Legionella Pneumonia

时间窗: 15 months

The diagnosis of Legionella pneumonia is made if the Legionella Urine Antigen Test is positive. The LUAT test kit utilized in this study will not be compared to the gold standard test for Legionellosis which would be the culture on specialised media/buffered-charcoal yeast extract (BCYE) plates, as this test is not available nationwide

次要结局

未报告次要终点

研究者

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

ALBERT ANTHONY

Pulmonologist/Principal Investigator

Ministry of Health, Malaysia

研究点 (1)

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