NCT02018198

FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test

DIStinguish Respiratory Underlying Pathogen associaTed Host Response in Acute Respiratory Infection: An Evaluation of FebriDx POC Test

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 540 (actual)
• Sponsor: Rapid Pathogen Screening · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

The aim of this study is to determine performance characteristics of the FebriDx test in predicting viral or bacterial infection etiology among febrile (observed or reported) patients presenting the emergency department, urgent care centers or primary care offices with suspected acute respiratory tract infection.

Detailed description

This is a prospective, multi-center, observational, blinded clinical trial whereby consented study subjects will be enrolled into two study cohorts: an Acute Respiratory Infection cohort and an Asymptomatic cohort. Subjects (children/adolescents, adults and elderly) with suspected community acquired Acute Respiratory Infection will be enrolled in the Acute Respiratory Infection cohort and subjects without infectious illness will be enrolled in the Asymptomatic cohort. All subjects will undergo FebriDx testing (study device) and results, blinded to subjects and treating physicians, will be compared to a Clinical Reference Algorithm supervised by clinical experts to arbitrate the presence and type of infection (bacterial or viral); the experts are also blinded to the results of FebriDx testing. The FebriDx® test is a rapid, point-of-care (POC) test that uses a fingerstick blood sample to identify patients with a pathogen induced host immune response through in-vitro detection of both Myxovirus resistance protein A (MxA) and c-reactive protein (CRP) directly from a whole blood sample. MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is an acute-phase inflammatory protein that is elevated in the presence of a systemic bacterial and/or viral infection.

Conditions

• Acute Respiratory Tract Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FebriDx	Point of Care Host Immune Response Test

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-04-30
• Completion: 2021-06-10
• First posted: 2013-12-23
• Last updated: 2022-11-17

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study