Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627166
Status:
TERMINATED
Last Update Posted:
None
First Post:
2023-03-12
Brief Title:
Viral Etiology of Severe Acute Respiratory InFection in CriticallY Ill Patients Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Virological Characterization of Severe Acute Respiratory Infection Using PCR-Based Methods and Metagenomic Sequencing a National Registry in Saudi Arabia
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to recruitment failure
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VERIFY
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None