Epidemiology Of Respiratory Virus Infections In Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01167361
First received: July 20, 2010
Last updated: October 30, 2012
Last verified: July 2011
  Purpose

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.


Condition
Respiratory Virus Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiology Of Respiratory Virus Infections In Children

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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. An aliquot from the leftover sample remaining after clinical diagnostic testing will be used for FilmArrayTM analysis


Enrollment: 350
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with an URTI or LRTI undergoing collection of respiratory secretions at St Jude by nasopharyngeal wash, nasopharyngeal swab, tracheal aspirate or bronchoalveolar lavage as ordered by the treating physician.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167361

Locations
United States, Tennessee
St . Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Ashok Srinivasan, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01167361     History of Changes
Other Study ID Numbers: XPD10-082 RESVPI
Study First Received: July 20, 2010
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
upper respiratory tract infection
lower respiratory tract infection

Additional relevant MeSH terms:
Virus Diseases

ClinicalTrials.gov processed this record on August 01, 2014