Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Primary Purpose
Respiratory Syncytial Virus, Human Metapneumovirus, Influenza
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nylon Flocked swab (Nasal secretion sampling)
Nylon Flocked swab (Nasal secretion sampling)
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Syncytial Virus focused on measuring Respiratory Syncytial virus, Bronchiolitis, Pediatric
Eligibility Criteria
Inclusion Criteria:
- Treating clinican ordered RSV antigen testing
Exclusion Criteria:
- Refusal of consent
- Age > 18 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Nylon Flocked swab Left Nasal Wash right
Nylon Flocked swab R Nasal Wash L
Nasal Wash Left Nylon Flocked swab Right
Nasal Wash R Nylon flocked swab L
Outcomes
Primary Outcome Measures
Viral detection rate by PCR
Secondary Outcome Measures
Full Information
NCT ID
NCT00613184
First Posted
January 29, 2008
Last Updated
February 11, 2008
Sponsor
Kern Medical Center
Collaborators
Medical Diagnostic Laboratories, LLC, Copan Innovation Murrietta, CA
1. Study Identification
Unique Protocol Identification Number
NCT00613184
Brief Title
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Official Title
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kern Medical Center
Collaborators
Medical Diagnostic Laboratories, LLC, Copan Innovation Murrietta, CA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Collection of nasal secretions from infants and toddlers for viral testing is usually done using the nasal washing technique described by Hall in 1975. This is cumbersome. Previous attempts to use swabs have been unsuccessful because the swabs didn't work well. A newly designed swab may work better and in this study we compare the new swab with the old style nasal washing.
.
Detailed Description
Collection of nasal secretions from infants and toddlers for viral testing is typically performed using the nasal saline aspirate technique described by Hall in 1975.
Nylon flocked swabs (NFS) and universal transport medium for room temperature (UTM-RT) (Copan Medical, Murrieta, CA) storage media have been found to be an effective collection and transport method for bacteria causing sexually transmitted infections.
We adapted these swabs and storage medium to collect respiratory viruses from children less than18 months old and compared detection rates using NFS and traditional nasal aspirates. We will determine the relative roles of the UTM-RT and NFS release and therefore measured viral detection rates of common respiratory pathogens in traditional saline aspirates stored in UTM-RT.
Our primary hypothesis is that nasal secretions collection using NFS stored in UTM-RT will lead to a higher detection rate of the respiratory viruses we arestudying; namely RSV, Influenza and human metapneumovirus from than collection of unpreserved saline nasal aspirates in children less than 18 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus, Human Metapneumovirus, Influenza, Bronchiolitis, Pediatric
Keywords
Respiratory Syncytial virus, Bronchiolitis, Pediatric
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nylon Flocked swab Left Nasal Wash right
Arm Title
2
Arm Type
Experimental
Arm Description
Nylon Flocked swab R Nasal Wash L
Arm Title
3
Arm Type
Experimental
Arm Description
Nasal Wash Left Nylon Flocked swab Right
Arm Title
4
Arm Type
Experimental
Arm Description
Nasal Wash R Nylon flocked swab L
Intervention Type
Device
Intervention Name(s)
Nylon Flocked swab (Nasal secretion sampling)
Intervention Description
Nasal Aspirate Nylon Flocked swab
Intervention Type
Device
Intervention Name(s)
Nylon Flocked swab (Nasal secretion sampling)
Intervention Description
Nylon flocked swab Nasal Wash
Primary Outcome Measure Information:
Title
Viral detection rate by PCR
Time Frame
0 not applicable
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treating clinican ordered RSV antigen testing
Exclusion Criteria:
Refusal of consent
Age > 18 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Walsh, MD
Organizational Affiliation
Kern Medical Center & David Geffen School of Medicine UCLA
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
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