Epidemiology Of Respiratory Virus Infections In Children

Respiratory Virus Infection Clinical Trial

Official title:

Epidemiology Of Respiratory Virus Infections In Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167361
• Other study ID #: XPD10-082 RESVPI
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: October 30, 2012
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Virus Infection
• Virus Diseases

Locations

Country	Name	City	State
United States	St . Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study measures the incidence of Respiratory virus (RV) infections in children with symptoms of an upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI) using the FilmArray System	This study uses FilmArrayTM System, a novel highly sensitive and rapid assay for respiratory virus infection. An aliquot from the leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM analysis	1 year	No
Secondary	Time of first detection of the virus as related to day of transplant, Time of first detection of the virus as related to day of chemotherapy and duration of viral shedding from the time of first detection will all be measured.	Different variables will be collected to find the association between Respiratory virus and clinical variables	1 year	No
Secondary	This study prospectively estimates and measures the duration of Respiratory Virus infections in symptomatic children by studying the epidemiology and natural history of infections with these viruses .	These viruses have been known to cause interstitial lung disease, will help clarify the etiology of "idiopathic pneumonia" post chemotherapy .	1 year	No
Secondary	This study analyses respiratory viruses using Filmarray TM method		1 year	No

External Links

•   St. Jude Children's Research Hospital