Emergency PanorOmic Wide Association Study in Respiratory Infectious Disease (ePWAS-RID)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- WHO-CPS
Study Overview
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
- Develop an ED-ID biobank (named ePWAS-RID). Phase 2
- Targeted research for the discovery of novel diagnostics, prognostics and therapeutics
Detailed Description
Introduction
Pandemic Preparedness
The COVID-19 pandemic has affected over 220 million people, claimed over 450 000 lives and invoked variable responses across the world. Delays in acquiring quality clinical and scientific material on the transmissibility, clinical nature, outcomes and lethality of novel and known infectious diseases (ID) translate into healthcare inefficiencies, societal and economic stress, and increased morbidity and mortality. Regions with greater success in the fight against COVID-19 were well prepared before the pandemic.
Pathogens
The pathogens most likely to cause annual epidemics and pandemics are respiratory viruses. In Asia, viral infections account for 30-40% of sepsis cases. Each year there are 100 million cases of viral community-acquired pneumonia (CAP) of which 60% progress to sepsis. These viruses cause host-mediated, inflammatory, immune responses which progresses through three phases: preliminary regulated inflammation; intermediate dysregulated proinflammation; and late dysregulated hypoinflammation.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •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).
- •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;
- •Toxidrome;
- •Non-organic acute psychosis.
Outcomes
Primary Outcomes
WHO-CPS
Time Frame: Up to 30 days
Differentiation of WHO-CPS \>6 from WHO-CPS ≤6
Secondary Outcomes
- Mortality(one year)
Investigators
Prof. Timothy Hudson RAINER
Professor of Department of Emergency Medicine
The University of Hong Kong