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Fingerstick test could help doctors skip unnecessary antibiotics

NCT ID NCT06746259

Diagnosis Sponsor: Lumos Diagnostics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether FebriDx, a rapid fingerstick test, can accurately tell bacterial from non-bacterial acute respiratory infections when used by people without lab training. Researchers compared results from untrained operators to trained ones in 800 patients with fever and respiratory symptoms. The goal was to see if the test is easy to use and reliable enough for quick, on-the-spot diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FebriDx fingerstick test
What this could lead to
If successful, this could make it easier to quickly diagnose respiratory infections without lab training, helping doctors decide whether antibiotics are needed.
What could go wrong
This is a completed observational study, not a treatment trial. The test may not be as accurate in real-world use, and results may not apply to all settings or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

800 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Symptomatic patients presenting to outpatient settings (e.g., physician offices, clinics, urgent care centers) with recent fever (reported within the last 72h) and recent symptoms of acute respiratory infection (symptoms reported to have started ≤ 7 days prior to study visit).

Ages

12 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or at the visit * Subject has clinical suspicion for Acute Respiratory Infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath Exclusion Criteria: * Subject is unable or unwilling to provide signed, Informed Consent * Subject is less than 12 years old or over 64 years old * Subject has a fever that started more than 3 days (\> 72 hours) prior to enrollment * Subject has symptoms of Acute Respiratory Infection that started \> 7 days of enrollment * Subject is receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days * Subject is in an immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy) * Subject has taken antibiotics or antiviral therapy in the last 14 days * Subject received a live viral immunization in the last 14 days * Subject has significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days * Subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days * Subject has a history of a myocardial infarction or stroke in the last 30 days

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory infections (ARIS)

Contacts and locations

Locations

  • Ascada Health

    Fullerton, California, 92835, United States

  • Ascada Health

    Katy, Texas, 77494, United States

  • Exer Urgent Care

    Pasadena, California, 91105, United States

  • HMG Clinical Research/Herrera Medical Group

    Bedford, Texas, 76021, United States

  • Hillcrest Medical Research, LLC

    Orange City, Florida, 32763, United States

  • Hometown Urgent Care and Research

    Beavercreek, Ohio, 45430, United States

  • L&C

    Miami, Florida, 33144, United States

  • Trujillo Medical Center

    Miramar, Florida, 33027, United States

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