Clinical trial NCT01167361: Epidemiology Of Respiratory Virus Infections In Children
Official title: Epidemiology Of Respiratory Virus Infections In Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Virus Infection
Keywords: upper respiratory tract infection
lower respiratory tract infection
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 350
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
measure: 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 .
timeFrame: 1 year
measure: This study analyses respiratory viruses using Filmarray TM method
timeFrame: 1 year
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St . Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Ashok Srinivasan, MD
role: PRINCIPAL_INVESTIGATOR
References: