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NCT06746259
FebriDx® Method Comparison Study Protocol
trial testing Rapid point of care test to detect host immune response in ARI in Acute Respiratory Infections (ARIs) in 800 participants. Completed in 31 August 2025.
15 August 2025
Quick facts
| Lead sponsor | Lumos Diagnostics |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 20 December 2024 |
| Primary completion | 15 August 2025 |
| Estimated completion | 31 August 2025 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Rapid point of care test to detect host immune response in ARI
Conditions studied
- Acute Respiratory Infections (ARIs) — all drugs for Acute Respiratory Infections (ARIs) →
Sponsor
Lumos Diagnostics
Who can join
Adults 12 to 64, any sex, with Acute Respiratory Infections (ARIs). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. The main question it aims to answer is: • Is FebriDx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? Trained and untrained participants will run the FebriDx test on patients with respiratory symptoms to evaluate comparability.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Trained Immunity in Health and Disease.
Yao M, Zhou J, Mei J, Gao C, et al · · 2025 · cited 3× · PMID 41211186 · DOI 10.1002/mco2.70461
Verify or expand the search:
- PubMed search for NCT06746259
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Respiratory Infections (ARIs)
Currently open trials in the same condition.
- NCT07211997 — FebriDx® Pediatric Validation Study · recruiting
Other Lumos Diagnostics trials
Trials by the same sponsor.
- NCT07211997 — FebriDx® Pediatric Validation Study · recruiting
- NCT05998109 — PheCheck Feasibility Study · completed
- NCT05403346 — Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™) · terminated
- NCT04750629 — Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™) · completed
- NCT04699903 — Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06746259 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lumos Diagnostics
- Last refreshed: 9 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06746259.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing