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FebriDx® Pediatric Validation Study

NCT07211997 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-10-31

No results posted yet for this study

Summary

The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.

Conditions

  • Acute Respiratory Infections (ARIs)

Interventions

DEVICE

FebriDx

Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood

Sponsors & Collaborators

  • Lumos Diagnostics

    lead INDUSTRY

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2026-10-31
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211997 on ClinicalTrials.gov