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Emergency PWAS in Respiratory Infectious Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05336851
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Timothy Hudson RAINER, The University of Hong Kong

Brief Summary:

Develop an emergency PanorOmics Wide Association Study (ePWAS) for the early, rapid biological and pathophysiological characterisation of known and novel Infectious Diseases in adult patients presenting to emergency departments with suspected, acute, community-acquired respiratory infectious disease (scaRID).

Phase 1

  1. Develop an ED-ID biobank (named ePWAS-RID). Phase 2
  2. Targeted research for the discovery of novel diagnostics, prognostics and therapeutics

Condition or disease Intervention/treatment
Viral Infections Bacterial Infections Fungal Infections Mixed Infection Mycobacterium Infection Infection of Uncertain Aetiology Pneumonia Sepsis Diagnostic Test: Biomarker blood draw and saliva collection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Emergency PanorOmic Wide Association Study in Respiratory Infectious Disease (ePWAS-RID)
Estimated Study Start Date : November 2, 2022
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025

Group/Cohort Intervention/treatment
Viral infection
Viral infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Bacterial infection
Bacterial infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Viral-Viral co-infection
Viral-viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Bacterial-Viral co-infection
Bacterial-Viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Fungal-Mycobacterium co-infection
Bacterial-Viral co-infection subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Infection of uncertain origin
Infection of uncertain origin subjects presenting within 8 days from symptom onset will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Control Subjects
Control group subjects, if they agree, will have at least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms (if applicable); and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if applicable); and c) 48 hours +/- 6 hours from symptom onset (if applicable).
Diagnostic Test: Biomarker blood draw and saliva collection
Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)




Primary Outcome Measures :
  1. WHO-CPS [ Time Frame: Up to 30 days ]
    Differentiation of WHO-CPS >6 from WHO-CPS ≤6


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Up to 30 days ]
    Mortality is defined as all-cause, Binary: Yes or No

  2. Mortality [ Time Frame: one year ]
    Mortality is defined as all-cause, Binary: Yes or No


Biospecimen Retention:   Samples With DNA

At least one whole blood and saliva drawn a) in the emergency department (if available) or hospital within 8 days of the onset of symptoms; and if they agree, a further two samples at b) 24 hours +/- 6 hours from symptom onset (if available); and c) 48 hours +/- 6 hours from symptom onset (if available).

Liquid biopsy for retention:

• Whole Blood samples, red blood cell effluent, plasma, white cell pellet(for genomic, epigenomic, transcriptomic and proteomic studies). serum (for proteomic, metabolomic and lipidomic studies), salivary supernatant, salivary cells. Biomarkers under investigation: DNA gene expression, RNA gene expression, Proteomics expression, Metabolomics expression and Lipidomics expression in peripheral blood and saliva



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Suspected, acute, community-acquired, respiratory, infectious disease presenting to emergency department with symptom onset <8 days and reported fever or chills or aural temperature >37.5°C
Criteria

Inclusion Criteria:

Patients eligible for enrolment include:

With reference to previous inclusion criteria are:

  • Adults ≥18 years of age; AND
  • Suspected, acute, community-acquired, respiratory, infectious disease (scaRID)*; AND
  • Informed consent.

Note: scaRID is defined according to ALL three criteria:

  1. Community acquired (not hospitalised for <28 days); AND
  2. Acute infection (defined as symptom onset <8 days and any ONE of reported fever or chills or aural temperature >37.5°C or hypothermia or leucocytosis or leucopaenia or new altered mental status); AND
  3. Probable respiratory infection - According to any ONE of:

    1. new cough or new sputum production or
    2. chest pain or
    3. dyspnoea or
    4. tachypnoea or
    5. abnormal lung examination or
    6. respiratory failure; or
    7. physician's judgment (presenting with systemic or gastrointestinal symptoms).

Control subjects will be drawn from two groups:

  • The worried well - adult patients with a National Early Warning Score (NEWS) <3 and a temperature <37.5°C.
  • Relatives or accompanying friends with no acute illness.

Exclusion Criteria:

  • Refusal of consent;
  • Recent hospitalisation (<28 days);
  • Enrolled in another clinical trial
  • Cellulitis;
  • Skin or orthopaedic infections;
  • Urinary tract infection;
  • Acute abdominal sepsis;
  • Sexual transmitted disease;
  • Human immunodeficiency virus (HIV) infection;
  • Immunocompromised/potential neutropenic fever;
  • Solid organ or haematopoietic stem-cell transplant within the previous 90 days;
  • Active graft-versus-host disease or bronchiolitis obliterans;
  • Severe traveller's disease requiring urgent hospitalisation and management including malaria, dengue, typhoid and other rickettsial diseases;
  • Stroke;
  • Toxidrome;
  • Non-organic acute psychosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336851


Contacts
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Contact: Timothy H Rainer, MD +852 39176846 thrainer@hku.hk

Locations
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China
Hong Kong University Recruiting
Hong Kong, China
Contact: Timothy H Rainer, MD    852 39176846    thrainer@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Timothy H Rainer, MD The University of Hong Kong
Additional Information:
Publications:
Pairo-Castineira E, Clohisey S, Klaric L, Bretherick AD, Rawlik K, Pasko D, Walker S, Parkinson N, Fourman MH, Russell CD, Furniss J, Richmond A, Gountouna E, Wrobel N, Harrison D, Wang B, Wu Y, Meynert A, Griffiths F, Oosthuyzen W, Kousathanas A, Moutsianas L, Yang Z, Zhai R, Zheng C, Grimes G, Beale R, Millar J, Shih B, Keating S, Zechner M, Haley C, Porteous DJ, Hayward C, Yang J, Knight J, Summers C, Shankar-Hari M, Klenerman P, Turtle L, Ho A, Moore SC, Hinds C, Horby P, Nichol A, Maslove D, Ling L, McAuley D, Montgomery H, Walsh T, Pereira AC, Renieri A; GenOMICC Investigators; ISARIC4C Investigators; COVID-19 Human Genetics Initiative; 23andMe Investigators; BRACOVID Investigators; Gen-COVID Investigators; Shen X, Ponting CP, Fawkes A, Tenesa A, Caulfield M, Scott R, Rowan K, Murphy L, Openshaw PJM, Semple MG, Law A, Vitart V, Wilson JF, Baillie JK. Genetic mechanisms of critical illness in COVID-19. Nature. 2021 Mar;591(7848):92-98. doi: 10.1038/s41586-020-03065-y. Epub 2020 Dec 11.
Taylor JC, Martin HC, Lise S, Broxholme J, Cazier JB, Rimmer A, Kanapin A, Lunter G, Fiddy S, Allan C, Aricescu AR, Attar M, Babbs C, Becq J, Beeson D, Bento C, Bignell P, Blair E, Buckle VJ, Bull K, Cais O, Cario H, Chapel H, Copley RR, Cornall R, Craft J, Dahan K, Davenport EE, Dendrou C, Devuyst O, Fenwick AL, Flint J, Fugger L, Gilbert RD, Goriely A, Green A, Greger IH, Grocock R, Gruszczyk AV, Hastings R, Hatton E, Higgs D, Hill A, Holmes C, Howard M, Hughes L, Humburg P, Johnson D, Karpe F, Kingsbury Z, Kini U, Knight JC, Krohn J, Lamble S, Langman C, Lonie L, Luck J, McCarthy D, McGowan SJ, McMullin MF, Miller KA, Murray L, Nemeth AH, Nesbit MA, Nutt D, Ormondroyd E, Oturai AB, Pagnamenta A, Patel SY, Percy M, Petousi N, Piazza P, Piret SE, Polanco-Echeverry G, Popitsch N, Powrie F, Pugh C, Quek L, Robbins PA, Robson K, Russo A, Sahgal N, van Schouwenburg PA, Schuh A, Silverman E, Simmons A, Sorensen PS, Sweeney E, Taylor J, Thakker RV, Tomlinson I, Trebes A, Twigg SR, Uhlig HH, Vyas P, Vyse T, Wall SA, Watkins H, Whyte MP, Witty L, Wright B, Yau C, Buck D, Humphray S, Ratcliffe PJ, Bell JI, Wilkie AO, Bentley D, Donnelly P, McVean G. Factors influencing success of clinical genome sequencing across a broad spectrum of disorders. Nat Genet. 2015 Jul;47(7):717-726. doi: 10.1038/ng.3304. Epub 2015 May 18.
Roadmap Epigenomics Consortium; Kundaje A, Meuleman W, Ernst J, Bilenky M, Yen A, Heravi-Moussavi A, Kheradpour P, Zhang Z, Wang J, Ziller MJ, Amin V, Whitaker JW, Schultz MD, Ward LD, Sarkar A, Quon G, Sandstrom RS, Eaton ML, Wu YC, Pfenning AR, Wang X, Claussnitzer M, Liu Y, Coarfa C, Harris RA, Shoresh N, Epstein CB, Gjoneska E, Leung D, Xie W, Hawkins RD, Lister R, Hong C, Gascard P, Mungall AJ, Moore R, Chuah E, Tam A, Canfield TK, Hansen RS, Kaul R, Sabo PJ, Bansal MS, Carles A, Dixon JR, Farh KH, Feizi S, Karlic R, Kim AR, Kulkarni A, Li D, Lowdon R, Elliott G, Mercer TR, Neph SJ, Onuchic V, Polak P, Rajagopal N, Ray P, Sallari RC, Siebenthall KT, Sinnott-Armstrong NA, Stevens M, Thurman RE, Wu J, Zhang B, Zhou X, Beaudet AE, Boyer LA, De Jager PL, Farnham PJ, Fisher SJ, Haussler D, Jones SJ, Li W, Marra MA, McManus MT, Sunyaev S, Thomson JA, Tlsty TD, Tsai LH, Wang W, Waterland RA, Zhang MQ, Chadwick LH, Bernstein BE, Costello JF, Ecker JR, Hirst M, Meissner A, Milosavljevic A, Ren B, Stamatoyannopoulos JA, Wang T, Kellis M. Integrative analysis of 111 reference human epigenomes. Nature. 2015 Feb 19;518(7539):317-30. doi: 10.1038/nature14248.

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Responsible Party: Prof. Timothy Hudson RAINER, Professor of Department of Emergency Medicine, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT05336851    
Other Study ID Numbers: ePWAS-RID/Rainer/2021
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Timothy Hudson RAINER, The University of Hong Kong:
Biobank
Diagnostics and Prognostics
Emergency Medicine
Multiomics and Panoromics
Respiratory Infectious Disease
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Mycobacterium Infections
Mycoses
Virus Diseases
Coinfection
Emergencies
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Actinomycetales Infections
Gram-Positive Bacterial Infections