FebriDx® Pediatric Validation Study

Conditions

• Acute Respiratory Infections (ARIs)

Eligibility Criteria

Sex

ALL

Age

2 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 9, 2025

Status verified

Oct 2025

Primary completion

Oct 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

800 participants (estimated)

Arms

• Arm: Acute Respiratory Infection
  Febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care centers or primary care offices with suspected acute respiratory tract infection.

Primary Outcome Measure

Performance of the FebriDx® test [ Time Frame: Day 1 ]

Central Contacts

• Catalina Suarez-Cuervo, MD
  7277765885
  [email protected]
• Catherine Borgiasz, ACRP-CP
  941-779-3078
  [email protected]

Locations (10)

Find similar trials in Colton, CA

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