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NCT06746259 · ClinicalTrials.gov registry record
FebriDx® Method Comparison Study Protocol
A clinical trial, sponsored by Lumos Diagnostics.
- Completed
- Registry status
- 800
- Enrollment target
NCT06746259: Completed study, sponsored by Lumos Diagnostics.
NCT06746259 is a clinical trial that has completed, run by Lumos Diagnostics. The registered enrollment target is 800 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06746259 has completed, sponsored by Lumos Diagnostics.
- COMPLETED
- Registry status
- 800 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Positive Percent Agreement (PPA), Negative Percent Agreement (NPA) and 95% confidence intervals will be calculated for each untrained operator and compared to performance in trained operators (truth).
Interventions
- DIAGNOSTIC_TEST Rapid point of care test to detect host immune response in ARI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2024-12-20 |
| Est. Completion | 2025-08-31 |
What the finished NCT06746259 record still lists
NCT06746259 is an observational study that tracks outcomes without assigning an intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Rapid point of care test to detect host immune response in ARI is the first listed.
NCT06746259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06746259 about?
NCT06746259 is a clinical study titled "FebriDx® Method Comparison Study Protocol". 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 bacteria...
What is the current status of trial NCT06746259?
This trial is currently completed. The enrollment target is 800 participants. The study started on 2024-12-20. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT06746259?
The interventions under investigation include: Rapid point of care test to detect host immune response in ARI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06746259?
This trial is sponsored by Lumos Diagnostics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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