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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-20

Study Completion Date

2022-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry

NCT04323787

Coronavirus

COMPLETED

Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure

NCT04411368

Acute Respiratory Failure Acute Respiratory Distress Syndrome

UNKNOWN

Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage

NCT01089400

Influenza Acute Lung Injury Acute Respiratory Distress Syndrome

COMPLETED

Lung and Systemic Inflammation in the Critically Ill Patient

NCT01906229

Acute Respiratory Distress Syndrome (ARDS) Systemic Inflammatory Response Syndrome (SIRS) Sepsis

TERMINATED

The Evaluation of NETs, Caspase-1 and Cytokines in ARDS Patients

NCT03227107

ARDS

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Acute Respiratory Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe Acute Respiratory Infection (SARI)

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* 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.