Acute Respiratory Infections (ARIs)NCT07211997
FebriDx® Pediatric Validation Study
An observational study of Acute Respiratory Infections (ARIs), run by Lumos Diagnostics at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Acute Respiratory Infections (ARIs)
- What is being tested?
- FebriDx
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Oct 2025to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Tribe
Charleston, South Carolina, 29407
Christine Butler, 843-766-6093, cbutler@tribecr.com
Philip McGaha, MD
- Recruiting
PAS Research- Myrtle Avenue Pediatrics, Inc
Clearwater, Florida, 33756
Brandi Baldwin, 813-330-3199, brandi8754@gmail.com
Karen Kelly, MD
- Not yet recruiting
Avacare
Colton, California, 92324
Susie Yela, 909- 503-9240, susana.yela@avacare.com
Brian Bearie, MD
- Recruiting
PAS Research
Edinburg, Texas, 78539
Zulma Pacheco, 813-330-3199, zulma@pas-research.com
Allan Mercado, MD
- Not yet recruiting
Tribe- Parkside Pediatrics
Greenville, South Carolina, 29607
Karleigh Williams, 864-334-0141, Kwilliams@tribecr.com
Scott Dobson, MD
- Recruiting
Hometown Urgent Care
Huber Heights, Ohio, 45424
Sherri Price, 937-236-8630, sprice@myhometownuc.com
Steve Choi, MD
- Recruiting
PAS Research- Sandhill Pediatrics PA
Lutz, Florida, 33549
Brandi Baldwin, 813-330-3199, brandi8754@gmail.com
Wendy Masterman, MD
- Recruiting
PAS Research
Pittsburgh, Pennsylvania, 15227
Kristy Cramer, 813-330-3199, kristy@pas-research.com
Steven Twan, MD
- Recruiting
Hometown Urgent Care
Springfield, Ohio, 45504
Sankeerth Motupalli, 937-322-6222, smotupalli@myhometownuc.com
Steve Choi, MD
- Recruiting
PAS Research
Tampa, Florida, 33613
Brandi Baldwin, 813-330-3199, brandi8754@gmail.com
Teena Hughes, MD
About this study
Official title: FebriDx® Pediatric Validation Study Protocol
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.
Read the detailed description
This is a prospective, multi-center, observational, blinded study where children with suspected acute respiratory infection will undergo FebriDx® testing.
The primary outcome is the presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm that includes pathogen detection testing (e.g., bacterial culture, multiplex PCR) as well as measures of host immune response.
FebriDx is a rapid lateral flow immunoassay for the visual, qualitative, in vitro detection of elevated levels of host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), directly from fingerstick blood.
- Conditions
- Acute Respiratory Infections (ARIs)
- Being tested
- FebriDx
- Keywords
- Pediatric, Host immune response, Biomarkers, Point-of-Care, Myxovirus resistance protein A (MxA), C-reactive protein (CRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebriDxDevice
Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FebriDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the FebriDx® test
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.
Measured: Day 1
FebriDx Performance
Positive and negative percent agreement Presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard
Measured: Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start9 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Infections (ARIs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumos Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211997
- Sponsor's protocol ID
- CLP-0021
- Other IDs
- 75A50124C000051
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FebriDx® Pediatric Validation Study Protocol
- ClinicalTrials.gov ID
- NCT07211997
- Acronym / sponsor ID
- CLP-0021
- Conditions
- Acute Respiratory Infections (ARIs)
- Keywords
- Pediatric, Host immune response, Biomarkers, Point-of-Care, Myxovirus resistance protein A (MxA), C-reactive protein (CRP)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Lumos DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multi-center, observational, blinded study where children with suspected acute respiratory infection will undergo FebriDx® testing.
The primary outcome is the presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm that includes pathogen detection testing (e.g., bacterial culture, multiplex PCR) as well as measures of host immune response.
FebriDx is a rapid lateral flow immunoassay for the visual, qualitative, in vitro detection of elevated levels of host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), directly from fingerstick blood.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Infection | – | Device: FebriDxFebrile pediatric patients (2-11 years) presenting to the emergency department, urgent care centers or primary care offices with suspected acute respiratory tract infection. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FebriDxBacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood | Device | Acute Respiratory Infection |
Primary outcome
Performance of the FebriDx® test
Time frame: Day 1
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.
FebriDx Performance
Time frame: Single visit
Positive and negative percent agreement Presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infections (ARIs), run by Lumos Diagnostics at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catalina Suarez-Cuervo, MD (7277765885, Clinicalstudies@lumosdiagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the FebriDx® test (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.