RADICAL II

Principal Investigator: Kwabena Ampofo
Keywords: Acute , Respiratory , Illness Department: Pediatric Administration
IRB Number: 00102879 Co Investigator:  
Specialty: Pediatrics, General
Sub Specialties: Adolescent Medicine
Recruitment Status: Recruiting

Contact Information

Fumiko Alger
fumiko.alger@hsc.utah.edu
801-213-4180

Brief Summary

PURPOSE:

The overall purpose of this study is to evaluate a host response assay based on a previously identified host gene expression classifier to discriminate bacterial, viral, or non-bacterial/non-viral (NB/NV) etiologies in patients with acute respiratory illness (ARI). 

Study Objectives

Since the HR-ARI test development program began, there have been significant advances in the technologies available for host transcriptional response measurement. With the support of the Antibacterial Resistance Leadership Group (ARLG, www.arlg.org) as well as the Defense Advanced Research Projects Agency (DARPA), we have worked on translating the HR-ARI test to a platform capable of rapidly and accurately measuring the host response in subjects presenting with ARI. 

  • Primary:
  • 1) Compare the Host Response-Acute Respiratory Illness (HR-ARI) test to a clinically adjudicated reference standard with respect to bacterial, viral, or non-bacterial/non-viral (NB/NV) etiologies.
  • Secondary:
  • 1) Evaluate performance of the HR-ARI test across age groups (2-11 years; 12- 21 years; 22-64 years; 65 or older)
  • 2) Evaluate performance of the HR-ARI test across racial and ethnic distributions
  • 3) Evaluate performance of the HR-ARI test across different enrollment sites
  • Exploratory:
  • 1) Evaluate performance of the HR-ARI test in clinical subgroups such as COPD, immunosuppressed, and those with atypical bacterial pathogens
  • (Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae).

Inclusion Criteria

Inclusion Criteria

Eligible subjects may be included in the study if they meet ALL of the following criteria at the Enrollment Visit:

a) Age 24 months or older

b) Acute respiratory illness of less than 28 days in duration

c) Acute respiratory illness will be defined by at least two qualifying symptoms OR or qualifying symptom and at least 1 qualifying vital sign abnormality:

  • Qualifying symptoms: headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing
  • Qualifying vital signs23,24

d) Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required procedures

Exclusion Criteria

Exclusion Criteria

Subjects will be excluded from the study if they meet ANY of the following criteria:

a) Known or suspected infection at any other anatomic site requiring antibacterial therapy.

b) Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.