Emergency PanorOmics Wide Association for Respiratory Infections

Emergency PanorOmic Wide Association Study in Respiratory Infectious Disease (ePWAS-RID)

This study is trying to quickly identify different respiratory infections in adults visiting the emergency room to help develop better tests and treatments for these illnesses.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: The University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT05336851 on ClinicalTrials.gov

What this trial studies

This study aims to develop an emergency PanorOmics Wide Association Study (ePWAS) to rapidly characterize known and novel infectious diseases in adults presenting to emergency departments with suspected acute respiratory infections. It involves creating a biobank for collecting clinical samples and data, which will be used for targeted research to discover new diagnostics, prognostics, and therapeutics. The study addresses the urgent need for improved preparedness and response to respiratory infectious diseases, particularly in light of the COVID-19 pandemic.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who present with suspected acute community-acquired respiratory infectious diseases.

Not a fit: Patients who are hospitalized for respiratory infections or those with chronic respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster and more accurate diagnostics and treatments for respiratory infections, ultimately improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using multiomics approaches for infectious disease characterization, suggesting potential success for this novel approach.

Eligibility 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.

Where this trial is running

Hong Kong

• Hong Kong University — Hong Kong, China (RECRUITING)

Study contacts

• Principal investigator: Timothy H Rainer, MD — The University of Hong Kong
• Study coordinator: Timothy H Rainer, MD

Conditions: Viral Infections, Bacterial Infections, Fungal Infections, Mixed Infection, Mycobacterium Infection, Infection of Uncertain Aetiology, Pneumonia, Sepsis