Performance of host response tests in acute respiratory infection

Comparison of the performance of Host Immune ResPonse tests for distinguishing bacterial and viral acute respiratory infection

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16512683

Enrollment

500

Registered

2025-05-16

Start date

2025-02-10

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparing diagnostic accuracy of different host response tests in acute respiratory illness in adults Respiratory

Interventions

Current interventions as of 17/09/2025: This study will consist of a diagnostic accuracy study comparing different host response tests (Febri-Dx, MeMed BV, Inflammatix TriVerity, Bi-VirTest) in resp

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Is a patient in the ED or AMU, Southampton General Hospital, UHS 2. Aged =18 years old 3. Able to be recruited and sampled within 24 hours of arrival in the ED or AMU 4. Has the capacity to consent to the study 5. Has at least one of the following acute respiratory symptoms: 5.1. Cough 5.2. Shortness of breath 5.3. Coryza 5.4. Sore Throat 5.5. Wheeze 5.6. Fever (where not definitively explained by another cause) 5.7. Reported exacerbation of a chronic respiratory condition (e.g., asthma, COPD)

Exclusion criteria

Exclusion criteria: 1. Not fulfilling all inclusion criteria 2. Declines nasal/pharyngeal swabbing, finger prick testing or venesection 3. Underlying severe bronchiectasis, cystic fibrosis, severe immune suppression

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 17/09/2025: Baseline characteristics and observations, routine biomakers (CRP, WBC, PCT) and respiratory viral PCR swab results. These results will be collected from the patient record from admission to ED/AMU. These results will be used for blinded clinical adjudication as the bases for diagnostic accuracy of the Febri-Dx, Bi-VirTest, MeMed BV, Inflammatix TriVerity test. _____ Previous primary outcome measure: Baseline characteristics and observations, routine biomakers (CRP, WBC, PCT) and respiratory viral PCR swab results. These results will be collected from the patient record from admission to ED/AMU. These results will be used for blinded clinical adjudication as the bases for diagnostic accuracy of the Febri-Dx, MeMed BV, Inflammatix TriVerity test.	—

Measure

Time frame

Current primary outcome measure as of 17/09/2025: Baseline characteristics and observations, routine biomakers (CRP, WBC, PCT) and respiratory viral PCR swab results. These results will be collected from the patient record from admission to ED/AMU. These results will be used for blinded clinical adjudication as the bases for diagnostic accuracy of the Febri-Dx, Bi-VirTest, MeMed BV, Inflammatix TriVerity test. _____ Previous primary outcome measure: Baseline characteristics and observations, routine biomakers (CRP, WBC, PCT) and respiratory viral PCR swab results. These results will be collected from the patient record from admission to ED/AMU. These results will be used for blinded clinical adjudication as the bases for diagnostic accuracy of the Febri-Dx, MeMed BV, Inflammatix TriVerity test.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Contacts

Public ContactAlex Tanner

A.Tanner@soton.ac.uk+44 (0)7946 715043

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026