Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-31 @ 2:03 PM
Study NCT ID:
NCT01167361
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2010-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology Of Respiratory Virus Infections In Children
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Epidemiology Of Respiratory Virus Infections In Children
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: