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

NCT06627166 | Terminated

• 1 other identifier: RC20-294-R
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Infection

Keywords

SARI; Critically ill; Infection; viruses

Outcome Measures

Primary Outcomes (1)

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

  Viral pathogens include influenza virus and MERS corona virus

  14 Days

Secondary Outcomes (4)

• Clinical features and response to treatment of SARI of different etiologies.

  90 days

• Clinical features and response to treatment of SARI of different etiologies.

  90 days

• Clinical features and response to treatment of SARI of different etiologies.

  90 days

• Clinical features and response to treatment of SARI of different etiologies.

  90 days

Study Arms (1)

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

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All eligible patients with SARI in critical care setting.

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with COVID-19
• Duration of illness \> 14 days since symptom onset
• 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.

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, Riyadh Region, 11426, Saudi Arabia

Location

Related Publications (4)

• Huai Y, Guan X, Liu S, Uyeki TM, Jiang H, Klena J, Huang J, Chen M, Peng Y, Yang H, Luo J, Zheng J, Peng Z, Huo X, Xiao L, Chen H, Zhang Y, Xing X, Feng L, Hu DJ, Yu H, Zhan F, Varma JK. Clinical characteristics and factors associated with severe acute respiratory infection and influenza among children in Jingzhou, China. Influenza Other Respir Viruses. 2017 Mar;11(2):148-156. doi: 10.1111/irv.12419. Epub 2016 Sep 20.

  PMID: 27465959 BACKGROUND

• Nguyen HKL, Nguyen SV, Nguyen AP, Hoang PMV, Le TT, Nguyen TC, Hoang HT, Vuong CD, Tran LTT, Le MQ. Surveillance of Severe Acute Respiratory Infection (SARI) for Hospitalized Patients in Northern Vietnam, 2011-2014. Jpn J Infect Dis. 2017 Sep 25;70(5):522-527. doi: 10.7883/yoken.JJID.2016.463. Epub 2017 Mar 28.

  PMID: 28367882 BACKGROUND

• Meerhoff TJ, Simaku A, Ulqinaku D, Torosyan L, Gribkova N, Shimanovich V, Chakhunashvili G, Karseladze I, Yesmagambetova A, Kuatbayeva A, Nurmatov Z, Otorbaeva D, Lupulescu E, Popovici O, Smorodintseva E, Sominina A, Holubka O, Onyshchenko O, Brown CS, Gross D. Surveillance for severe acute respiratory infections (SARI) in hospitals in the WHO European region - an exploratory analysis of risk factors for a severe outcome in influenza-positive SARI cases. BMC Infect Dis. 2015 Jan 8;15:1. doi: 10.1186/s12879-014-0722-x.

  PMID: 25567701 BACKGROUND

• Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011 Apr 9;377(9773):1264-75. doi: 10.1016/S0140-6736(10)61459-6. Epub 2011 Mar 22.

  PMID: 21435708 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal swab, MINI BAL samples, Serum samples, Plasma sample, and Blood sample

MeSH Terms

Conditions

Critical Illness; Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yaseen Arabi

  King Abdulaziz Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman intensive care unit

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: October 4, 2024
• Study Start: March 20, 2022
• Primary Completion: April 18, 2022
• Study Completion: June 22, 2022
• Last Updated: October 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)