A COMPARISON OF RSV VIRAL LOADS BETWEEN NASOPHARYNGEAL AND MID-TURBINATE SWABS FROM CHILDREN <24 MONTHS WITH RSV INFECTION

Principal Investigator: Anne Blaschke
Keywords: Viral Loads , Naso-Pharyngeal , Mid-turbinate Department: Pediatric Administration
IRB Number: 00087122 Co Investigator:  
Specialty: Pediatrics, General
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Julianna Dorsch
Julianna.Dorsch@hsc.utah.edu
801-587-5200

Brief Summary

The purpose of this study is find out if MT (mid-turbinate) swabs can be used to correctly measure viral loads in the same way that NP (Nasopharynx) swabs do. MT swabs are more comfortable for the patient, but there is little data on their use in viral load measurement. This study will compare viral load measurements from patients who have both types of swab (NP and MT) performed. Medical data will be collected from this RSV hospitalization to help us understand how the viral load information relates to how sick the child is.

 

Objectives:

  1. Compare the RSV viral load from flocked swabs collected from the nasopharynx  (NP) vs. the middle turbinate (MT) of infants <24 months admitted to the hospital with symptomatic RSV infection.
  2. Evaluate the relationship between RSV viral load and RSV symptoms and severity

Inclusion Criteria

Inclusion Criteria:

  1. Age <24 months
  2. Physician diagnosed upper/lower respiratory tract infection
  3. ≥ 28 weeks gestational age at birth with an adjusted gestational age (actual gestational age (weeks) plus chronological age (weeks) of ≥ 40 weeks
  4. Confirmed diagnosis of RSV (PCR-based or rapid antigen) obtained at PCH or confirmable within the Intermountain Healthcare EMR.
  5. Admitted to Primary Children’s Hospital (PCH)
  6. Willing to comply with all study procedures
  7. Subject’s parent of caregiver understands and reads English
  8. Time from inpatient admission to sample collection <72 hours

 

 

Exclusion Criteria

Exclusion Criteria:

  1. Age >= 24 months
  2. Asymptomatic
  3. Mechanically ventilated
  4. Unable to provide either the NP or MT specimen
  5. Use of any investigational medicinal products in the 28 days prior to Screening, OR use of any investigational RSV vaccine ever