Epidemiology Of Respiratory Virus Infections In Children

St. Jude Children's Research Hospital

Status: Completed

Conditions: Respiratory Virus Infection

Study type: Observational

Funder types: Other

Identifiers

NCT01167361

XPD10-082 RESVPI

Details and patient eligibility

About

This study aims to prospectively estimate the incidence of Respiratory virus (RV) infections in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI) at St. Jude Children's Research Hospital (SJCRH) using the FilmArrayTM System, a novel highly sensitive and rapid assay for RV detection. An aliquot from the leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM analysis. Patients will be accrued on the study over a one year period.

Full description

The Primary Objective of the study is:

• Prospectively estimate the incidence of Respiratory virus (RV) infections in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI) at St. Jude Children's Research Hospital(SJCRH).

The Secondary Objectives of the study are:

• Study the association between RV infections and clinical variables.
• Prospectively estimate the duration of RV infections in symptomatic children at SJCRH.
• Compare the sensitivity and specificity of the current molecular method of analysis of respiratory viruses with the FilmArrayTM method.

Enrollment: 350 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Birth to less than or equal to 18 years.
• Patients with an URTI or LRTI undergoing collection of respiratory secretions at SJCRH, by nasopharyngeal wash, nasopharyngeal swab, tracheal aspirate or bronchoalveolar lavage as ordered by the treating physician.

Trial design

350 participants in 1 patient group

Children with upper or lower respiratory infections

Description:

Respiratory Virus infections in children who are symptomatic with either an Upper Respiratory Tract Infections and/or Lower Respiratory Tract Infections is determined by using a novel highly sensitive and rapid assay for RV detection. An aliquot from the leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM analysis. Specimens collected will include nasopharyngeal washes, nasopharyngeal swabs, tracheal aspirates and bronchoalveolar lavage as ordered by the treating physician. Diagnostic studies on this specimen will be performed as ordered and the results will be available to the treating physicians after reporting.