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临床试验/NCT06627166
NCT06627166终止不适用

Clinical and Virological Characterization of Severe Acute Respiratory Infection Using PCR-Based Methods and Metagenomic Sequencing: a National Registry in Saudi Arabia

King Abdullah International Medical Research Center1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Prevalence of different viral and bacterial pathogens among critically ill patients with SARI

研究概览

简要总结

SARI is a major public health problem in Saudi Arabia and leads to considerable morbidity and mortality. Most SARI-related mortality occurs in patients admitted to ICUs across the country. RVIs alone and as precipitating causes of bacterial co-infections are under-recognized as causes of critical SARI. Therefore, data regarding the role of RVIs in critically ill patients with SARI in Saudi Arabia are greatly needed to fill the current gaps with respect to pathogens, disease pathogenesis, current treatment approaches, and clinical outcomes.

In the VERIFY multicenter national registry, we aim to determine the viral etiologies of SARI in mechanically ventilated critically ill patients. We aim to collect inventory samples (blood, and nasopharyngeal swabs, mini BAL) from >10 sites in Saudi Arabia from different regions to enhance generalizability of data.

详细描述

Data on the burden, severity and etiology of SARI amongst critically ill patients will be expected to be of a great value in guiding the prioritization of prevention and control efforts18 and in the design of future intervention studies of antivirals and other therapeutic modalities.

Because influenza is a common cause of serious respiratory illness in Saudi Arabia, although only limited data are available on the most severely ill patients with influenza, we will conduct surveillance in SARI critically ill patients and perform typing and subtyping of influenza viruses in BAL samples. We will store samples for future examination of predisposing risk factors including genetic factors.

Multiplex PCR will reduce the cost and time to detect the respiratory pathogens. In recent years, the falling costs of Whole Genome Sequencing (WGS) technologies have has proven to be a valuable tool to understand the growing threat of emerging pathogens. Metagenomic next-generation sequencing (M-NGS) has transformative effect in the last decade to investigate and understand complex microbial communities. M-NGS is simply capturing and determining all nucleic acids in a sample which allowed to identify a mixed population of microorganisms. This powerful platform simultaneously identifies genetics materials of any organisms unbiased to other methods that used specific primers to identify specific targets.

The primary objective of the VERIFY registry is to examine the virological etiologies of SARI among mechanically ventilated critically ill patients in a geographical representative sample from Saudi Arabia in order to obtain a better estimate of viral pathogen prevalence by systematic lower respiratory tract sampling and use of serology among critically ill patients in a geographical representative sample from Saudi Arabia. Contribution of viruses may be under-estimated due to the use of upper respiratory tract specimens only, and late presentation of cases to ICU (at which time antigen is no longer detectable). Therefore a systematic approach using mini-BAL to obtain lower respiratory samples will likely yield better estimate.

研究设计

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

入排标准

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

入选标准

  • Adults (≥14 years old) patients
  • A clinical presentation consistent with community-acquired SARI/pneumonia
  • AND admitted to the ICU because of respiratory failure or sepsis
  • AND is invasively mechanically ventilated.

排除标准

  • Diagnosed with COVID-19
  • Duration of illness > 14 days since symptom onset
  • Did not meet inclusion criteria in the first 48 hrs of admission to the ICU.
  • Patient already enrolled in the study
  • Participant or legal guardian refuses to participate in the study.
  • Diagnosis is not related to SARI
  • Enrolled in interventional trial of investigational therapeutics for pneumonia.

结局指标

主要结局

Prevalence of different viral and bacterial pathogens among critically ill patients with SARI

时间窗: 14 Days

Viral pathogens include influenza virus and MERS corona virus

次要结局

  • Clinical features and response to treatment of SARI of different etiologies.(90 days)

研究者

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

Dr Yaseen Arabi

Chairman intensive care unit

King Abdullah International Medical Research Center

研究点 (1)

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