Viral Etiology of Severe Acute Respiratory InFection in CriticallY Ill Patients Registry (VERIFY)

King Abdullah International Medical Research Center

Status: Terminated

Conditions: Severe Acute Respiratory Infection

Study type: Observational

Funder types: Other

Identifiers

NCT06627166

RC20-294-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

13 participants in 1 patient group

Severe Acute Respiratory Infection (SARI)

Description:

Nasopharyngeal swab, MINI BAL samples, Serum samples, Plasma sample, and Blood sample (RNA) will be collected from patients on day 0 (baseline) of enrollment, and on day 14 of enrollment. SAMPLING PROCEDURES: 1. Nucleic acid extraction 2. Polymerase chain reaction (PCR) 2.1 Testing for MERS-CoV will be performed by RT-PCR 2.2 We will test for Infleunza H and N PCR for influenza H 2.3 We will also test for a panel of viruses using PCR multiplex that includes influenza A ; influenza B ; influenza C ; influenza A (H1N1) swl ; parainfluenza viruses 1, 2, 3 and 4 ; coronaviruses NL63, 229E, OC43 and HKU1; human metapneumoviruses A/B; rhinovirus ;respiratory syncytial viruses A and B; adenovirus; enterovirus; parechovirus; bocavirus. 3.16S PCR and sanger sequencing for bacterial detection 4.Metagenomics /Next Generation Sequencing 5.Microbiome bioinformatics analysis