Severe Acute Respiratory InfectionVERIFYNCT06627166
Viral Etiology of Severe Acute Respiratory InFection in CriticallY Ill Patients Registry
An observational study of Severe Acute Respiratory Infection, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Severe Acute Respiratory Infection
- How many people
- 13 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Mar 2022to 22 Jun 2022
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All eligible patients with SARI in critical care setting.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Riyadh Region, 11426
About this study
Official title: Clinical and Virological Characterization of Severe Acute Respiratory Infection Using PCR-Based Methods and Metagenomic Sequencing: a National Registry in Saudi Arabia
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.
Read the 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.
- Conditions
- Severe Acute Respiratory Infection
- Keywords
- SARI, Critically ill, Infection, viruses
- Medical subject headings
- Critical Illness, Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different viral and bacterial pathogens among critically ill patients with SARI
Viral pathogens include influenza virus and MERS corona virus
Measured: 14 Days
Secondary outcomes (4)
Clinical features and response to treatment of SARI of different etiologies.
Clinical data collection include demographic (Age in years, BMI in kg/m^2)
Measured: 90 days
Clinical features and response to treatment of SARI of different etiologies.
Risk factors (Admission diagnosis, smoking, chronic comorbidities)
Measured: 90 days
Clinical features and response to treatment of SARI of different etiologies.
Clinical course in the ICU (mechanical ventilation, vasopressor use, renal replacement therapy, tracheostomy)
Measured: 90 days
Clinical features and response to treatment of SARI of different etiologies.
outcomes (90 day mortality, ICU length of stay, hospital length of stay, mechanical ventilation duration)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start20 Mar 2022
- Primary completion18 Apr 2022
- Study completion22 Jun 2022
Why it stopped: Due to recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yaseen Arabi, King Abdullah International Medical Research Center
- Investigators
- Yaseen Arabi, Principal investigator, King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627166
- Sponsor's protocol ID
- RC20-294-R
- Acronym
- VERIFY
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27465959Nguyen 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.
PubMed 28367882Meerhoff 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.
PubMed 25567701Ruuskanen 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.
PubMed 21435708
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Virological Characterization of Severe Acute Respiratory Infection Using PCR-Based Methods and Metagenomic Sequencing: a National Registry in Saudi Arabia
- ClinicalTrials.gov ID
- NCT06627166
- Acronym / sponsor ID
- VERIFY / RC20-294-R
- Conditions
- Severe Acute Respiratory Infection
- Keywords
- SARI, Critically ill, Infection, viruses
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to recruitment failure
- Enrolment
- 13 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients with SARI in critical care setting.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of different viral and bacterial pathogens among critically ill patients with SARI
Time frame: 14 Days
Viral pathogens include influenza virus and MERS corona virus
4 secondary outcomes
Clinical features and response to treatment of SARI of different etiologies.
Time frame: 90 days
Clinical features and response to treatment of SARI of different etiologies.
Time frame: 90 days
Clinical features and response to treatment of SARI of different etiologies.
Time frame: 90 days
Clinical features and response to treatment of SARI of different etiologies.
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Due to recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 27465959Huai 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.
- Background: PubMed 28367882Nguyen 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.
- Background: PubMed 25567701Meerhoff 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.
- Background: PubMed 21435708Ruuskanen 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.
- Individual participant dataSharing planned: No
Related trials for Severe Acute Respiratory Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
Not yet recruitingPhase 3
Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older
Immunization, Healthy Volunteers
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaseen Arabi principal investigator
King Abdulaziz Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Infection, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to recruitment failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different viral and bacterial pathogens among critically ill patients with SARI (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06627166, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.