Emergency PWAS in Respiratory Infectious Disease

NCT05336851 | Recruiting

• 1 other identifier: ePWAS-RID/Rainer/2021
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Viral Infections; Bacterial Infections; Fungal Infections; Mixed Infection; Mycobacterium Infection; Infection of Uncertain Aetiology; Pneumonia; Sepsis

Keywords

Biobank; Diagnostics and Prognostics; Emergency Medicine; Multiomics and Panoromics; Respiratory Infectious Disease

Outcome Measures

Primary Outcomes (1)

• WHO-CPS

  Differentiation of WHO-CPS \>6 from WHO-CPS ≤6

  Up to 30 days

Secondary Outcomes (2)

• Mortality

  Up to 30 days

• Mortality

  one year

Study Arms (7)

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

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

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

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

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

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

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

Interventions

Biomarker blood draw and saliva collection DIAGNOSTIC_TEST

Three peripheral 10 - 20mL blood sample (if available) Three 1 - 5mL salivary samples (if available)

Bacterial infection; Bacterial-Viral co-infection; Control Subjects; Fungal-Mycobacterium co-infection; Infection of uncertain origin; Viral infection; Viral-Viral co-infection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients eligible for enrolment include:
• 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:
• Community acquired (not hospitalised for \<28 days); AND
• 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
• Probable respiratory infection - According to any ONE of:
• new cough or new sputum production or
• chest pain or
• dyspnoea or
• tachypnoea or
• abnormal lung examination or
• respiratory failure; or
• physician's judgment (presenting with systemic or gastrointestinal symptoms).

You may not qualify if:

• 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;

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Hong Kong University

Hong Kong, China

RECRUITING

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Related Links

• The Human Protein Atlas. Accessed 15th September 2021
• Hall A. Eight things you should consider before setting up a biobank. Human Tissue Authority. Accessed on 15th September 2021
• Accessed on 22nd July 2021
• Accessed on 22nd July 2021
• Coronavirus (COVID-19). Accessed 16th September 2021

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

MeSH Terms

Conditions

Virus Diseases; Bacterial Infections; Mycoses; Coinfection; Mycobacterium Infections; Pneumonia; Sepsis

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Gram-Positive Bacterial Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy H Rainer, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy H Rainer, MD

CONTACT

+852 39176846; thrainer@hku.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Emergency Medicine

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: April 11, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)