Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2025-10-09
2026-11-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
FebriDx
Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood
Interventions
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FebriDx
Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
11 Years
ALL
No
Sponsors
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Lumos Diagnostics
INDUSTRY
Responsible Party
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Locations
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Avacare
Colton, California, United States
PAS Research- Myrtle Avenue Pediatrics, Inc
Clearwater, Florida, United States
PAS Research- Sandhill Pediatrics PA
Lutz, Florida, United States
PAS Research
Tampa, Florida, United States
Hometown Urgent Care
Huber Heights, Ohio, United States
Hometown Urgent Care
Springfield, Ohio, United States
PAS Research
Pittsburgh, Pennsylvania, United States
Tribe
Charleston, South Carolina, United States
Tribe- Parkside Pediatrics
Greenville, South Carolina, United States
PAS Research
Edinburg, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Susie Yela
Role: primary
Brandi Baldwin
Role: primary
Brandi Baldwin
Role: primary
Brandi Baldwin
Role: primary
Sherri Price
Role: primary
Sankeerth Motupalli
Role: primary
Kristy Cramer
Role: primary
Christine Butler
Role: primary
Karleigh Williams
Role: primary
Zulma Pacheco
Role: primary
Other Identifiers
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75A50124C000051
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CLP-0021
Identifier Type: -
Identifier Source: org_study_id