FebriDx® Pediatric Validation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FebriDx.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Infections (ARIs). Basic parameters: 2 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FebriDx® Pediatric Validation Study Protocol
Overview
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.
Interventions
- Device FebriDx
Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood
Primary outcome measures
- Performance of the FebriDx® test [Time frame: Day 1]
- FebriDx Performance [Time frame: Single visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 10 centers
- Avacare — Colton
- PAS Research- Myrtle Avenue Pediatrics, Inc — Clearwater
- PAS Research- Sandhill Pediatrics PA — Lutz
- PAS Research — Tampa
- Hometown Urgent Care — Huber Heights
- Hometown Urgent Care — Springfield
- PAS Research — Pittsburgh
- Tribe — Charleston
- … and 2 more centers
Identifiers
NCT: NCT07211997 · CLP-0021 · 75A50124C000051