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NCT07211997 · ClinicalTrials.gov registry record
FebriDx® Pediatric Validation Study
A clinical trial of Acute Respiratory Infections (ARIs), sponsored by Lumos Diagnostics.
- Recruiting
- Registry status
- 800
- Enrollment target
- 10
- Study locations
NCT07211997: Recruiting study of Acute Respiratory Infections (ARIs), sponsored by Lumos Diagnostics.
NCT07211997 is a study of Acute Respiratory Infections (ARIs) that is actively recruiting participants, run by Lumos Diagnostics. The registered enrollment target is 800 participants, above the 97-participant average among 3 other Acute Respiratory Infections (ARIs) trials with a reported enrollment target (725% higher). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07211997, a study of Acute Respiratory Infections (ARIs), is actively recruiting participants, sponsored by Lumos Diagnostics.
- RECRUITING
- Registry status
- 800 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of the FebriDx results in determining the presence of a bacterial associated systemic host immune response compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm.
Conditions Studied
Interventions
- DEVICE FebriDx
Study Locations (10)
Florida
- PAS Research- Myrtle Avenue Pediatrics, Inc - Clearwater
- PAS Research- Sandhill Pediatrics PA - Lutz
- PAS Research - Tampa
Ohio
- Hometown Urgent Care - Huber Heights
- Hometown Urgent Care - Springfield
South Carolina
- Tribe - Charleston
- Tribe- Parkside Pediatrics - Greenville
California
- Avacare - Colton
Pennsylvania
- PAS Research - Pittsburgh
Texas
- PAS Research - Edinburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2025-10-09 |
| Est. Completion | 2026-11-30 |
What NCT07211997 shows while recruiting
NCT07211997 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, above the 97-participant average among 3 other Acute Respiratory Infections (ARIs) trials with a reported enrollment target (725% higher).
The record links to 1 condition, with Acute Respiratory Infections (ARIs) appearing as the primary indexed condition, and to 1 intervention - of which FebriDx is the first listed.
NCT07211997 lists 10 locations in 6 states (Florida, Ohio, South Carolina).
Frequently Asked Questions
What is clinical trial NCT07211997 about?
NCT07211997 is a clinical study titled "FebriDx® Pediatric Validation Study". 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 suspect...
What is the current status of trial NCT07211997?
This trial is currently recruiting. The enrollment target is 800 participants. The study started on 2025-10-09. Estimated completion is 2026-11-30.
What conditions does trial NCT07211997 study?
This clinical trial studies the following conditions: Acute Respiratory Infections (ARIs).
What interventions are being tested in trial NCT07211997?
The interventions under investigation include: FebriDx (DEVICE).
Who is sponsoring clinical trial NCT07211997?
This trial is sponsored by Lumos Diagnostics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07211997 being conducted?
This trial has 10 study locations across California, Florida, Ohio, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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