Due to recruitment failure
VERIFY
Clinical and Virological Characterization of Severe Acute Respiratory Infection Using PCR-Based Methods and Metagenomic Sequencing: a National Registry in Saudi Arabia
Sponsor study identifier
observational
13
1 country
1
Study Start
March 20, 2022
Actual (reported)Primary Completion
April 18, 2022
Actual (reported)Study Completion
June 22, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 22, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2022
Actual (reported)April 18, 2022
Actual (reported)June 22, 2022
Actual (reported)March 12, 2023
Actual (reported)October 4, 2024
Actual (reported)Prevalence of different viral and bacterial pathogens among critically ill patients with SARI
Viral pathogens include influenza virus and MERS corona virus
14 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
Clinical features and response to treatment of SARI of different etiologies.
90 days
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
All eligible patients with SARI in critical care setting.
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Riyadh Region, 11426, Saudi Arabia
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.
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.
Nasopharyngeal swab, MINI BAL samples, Serum samples, Plasma sample, and Blood sample
Yaseen Arabi
King Abdulaziz Medical City
13 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2023
First Posted
October 4, 2024
Study Start
March 20, 2022
Actual (reported)Severe Acute Respiratory Infections (SARI) in Belgium (2011-2020)
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
April 18, 2022
Actual (reported)Study Completion
June 22, 2022
Actual (reported)Last Updated
October 4, 2024
Record last verified: 2024-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: