Epidemiology Of Respiratory Virus Infections In Children
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|ClinicalTrials.gov Identifier: NCT01167361|
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : October 31, 2012
|Condition or disease|
|Respiratory Virus Infection|
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.
|Study Type :||Observational|
|Actual Enrollment :||350 participants|
|Official Title:||Epidemiology Of Respiratory Virus Infections In Children|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Children with upper or lower respiratory infections
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.
- 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 [ Time Frame: 1 year ]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
- 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. [ Time Frame: 1 year ]Different variables will be collected to find the association between Respiratory virus and clinical variables
- 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 . [ Time Frame: 1 year ]These viruses have been known to cause interstitial lung disease, will help clarify the etiology of "idiopathic pneumonia" post chemotherapy .
- This study analyses respiratory viruses using Filmarray TM method [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167361
|United States, Tennessee|
|St . Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Ashok Srinivasan, MD||St. Jude Children's Research Hospital|