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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
Kern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Syncytial Virus focused on measuring Respiratory Syncytial virus, Bronchiolitis, Pediatric

Eligibility Criteria

undefined - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 29, 2008
    Last Updated
    February 11, 2008
    Sponsor
    Kern Medical Center
    Collaborators
    Medical Diagnostic Laboratories, LLC, Copan Innovation Murrietta, CA
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    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

    Learn more about this trial

    Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses

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