FebriDx® Pediatric Validation Study
Purpose
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.
Condition
- Acute Respiratory Infections (ARIs)
Eligibility
- Eligible Ages
- Between 2 Years and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Clearwater, Florida 33756
Lutz, Florida 33549
Huber Heights, Ohio 45424
Springfield, Ohio 45504
Pittsburgh, Pennsylvania 15227
More Details
- Status
- Recruiting
- Sponsor
- Lumos Diagnostics
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.