Respiratory Virus InfectionNCT01167361
Epidemiology Of Respiratory Virus Infections In Children
An observational study of Respiratory Virus Infection, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Virus Infection
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Respiratory Virus Infection
- Keywords
- upper respiratory tract infection, lower respiratory tract infection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
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 .
Measured: 1 year
This study analyses respiratory viruses using Filmarray TM method
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Virus InfectionStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashok Srinivasan, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167361
- Sponsor's protocol ID
- XPD10-082 RESVPI
- Status last verified
- Jul 2011
- First submitted
- 20 Jul 2010
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology Of Respiratory Virus Infections In Children
- ClinicalTrials.gov ID
- NCT01167361
- Acronym / sponsor ID
- XPD10-082 RESVPI
- Conditions
- Respiratory Virus Infection
- Keywords
- upper respiratory tract infection, lower respiratory tract infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
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
This study analyses respiratory viruses using Filmarray TM method
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Srinivasan, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Virus Infection, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.