FebriDx® Pediatric Validation Study

ConditionAcute Respiratory Infections (ARIs)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age2-11

SponsorLumos Diagnostics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

FebriDx
Device
Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood

Treatment groups

800 Participants

are divided into 1 treatment group

Group A: Acute Respiratory Infection1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Time frame

Single visit

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lumos Diagnostics

Lead sponsor

Source ClinicalTrials.gov

Apply now