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New Finger-Prick test could slash unnecessary antibiotics in kids

NCT ID NCT07211997

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study is testing a finger-prick blood test called FebriDx in 800 children aged 2-11 who have a fever and symptoms of a respiratory infection. The goal is to see if the test can quickly tell whether the infection is caused by bacteria or something else (like a virus). If accurate, this could help doctors decide when antibiotics are truly needed, reducing unnecessary use.

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

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

May 2027

An estimate. End dates often move.

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

Pediatric patients presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection

Ages

2 to 11 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: * Signed informed consent by parent/guardian and Assent for ages 7-11 years * Exhibit or report of a new onset measured temperature (oral or tympanic) of greater than or equal to 100.4°F/38°C within 3 days (72 hours) of enrollment * Clinical suspicion for Acute Respiratory Infection beginning within 7 days before enrollment AND presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice, shortness of breath / difficulty breathing Exclusion Criteria: * Unwilling to participate in 7-day follow-up or sign HIPAA waiver to obtain medical record if hospitalized * Immunocompromised state or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral / inhaled steroids, Methotrexate, Cyclosporine, Chemotherapy, interferon therapy) * Taking antibiotics or antiviral therapy in the last 14 days * Received a live viral immunization in the last 14 days * Clinical diagnosis of otitis media or recognizable viral syndrome (i.e., croup, varicella, stomatitis) at the time of enrollment * Prior enrollment in the study

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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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Avacare

    NOT_YET_RECRUITING

    Colton, California, 92324, United States

  • Hometown Urgent Care

    RECRUITING

    Huber Heights, Ohio, 45424, United States

  • Hometown Urgent Care

    RECRUITING

    Springfield, Ohio, 45504, United States

  • PAS Research

    RECRUITING

    Tampa, Florida, 33613, United States

  • PAS Research

    RECRUITING

    Pittsburgh, Pennsylvania, 15227, United States

  • PAS Research

    RECRUITING

    Edinburg, Texas, 78539, United States

  • PAS Research- Myrtle Avenue Pediatrics, Inc

    RECRUITING

    Clearwater, Florida, 33756, United States

  • PAS Research- Sandhill Pediatrics PA

    RECRUITING

    Lutz, Florida, 33549, United States

  • Tribe

    RECRUITING

    Charleston, South Carolina, 29407, United States

  • Tribe- Parkside Pediatrics

    NOT_YET_RECRUITING

    Greenville, South Carolina, 29607, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.