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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Kern Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613184
First Posted: February 12, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Diagnostic Laboratories, LLC
Copan Innovation Murrietta, CA
Information provided by:
Kern Medical Center
January 29, 2008
February 12, 2008
October 12, 2017
November 2006
January 2008   (Final data collection date for primary outcome measure)
Viral detection rate by PCR [ Time Frame: 0 not applicable ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Respiratory Syncytial Virus
  • Human Metapneumovirus
  • Influenza
  • Bronchiolitis
  • Pediatric
  • Device: Nylon Flocked swab (Nasal secretion sampling)
    Nasal Aspirate Nylon Flocked swab
  • Device: Nylon Flocked swab (Nasal secretion sampling)
    Nylon flocked swab Nasal Wash
  • Experimental: 1
    Nylon Flocked swab Left Nasal Wash right
    Interventions:
    • Device: Nylon Flocked swab (Nasal secretion sampling)
    • Device: Nylon Flocked swab (Nasal secretion sampling)
  • Experimental: 2
    Nylon Flocked swab R Nasal Wash L
    Intervention: Device: Nylon Flocked swab (Nasal secretion sampling)
  • Experimental: 3
    Nasal Wash Left Nylon Flocked swab Right
    Intervention: Device: Nylon Flocked swab (Nasal secretion sampling)
  • Experimental: 4
    Nasal Wash R Nylon flocked swab L
    Intervention: Device: Nylon Flocked swab (Nasal secretion sampling)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treating clinican ordered RSV antigen testing

Exclusion Criteria:

  • Refusal of consent
  • Age > 18 months
Sexes Eligible for Study: All
up to 18 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00613184
kmc06037
No
Not Provided
Not Provided
Paul Walsh MB BCh FACEP, Department of Emergency Medicine, Kern Medical Center
Kern Medical Center
  • Medical Diagnostic Laboratories, LLC
  • Copan Innovation Murrietta, CA
Principal Investigator: Paul Walsh, MD Kern Medical Center & David Geffen School of Medicine UCLA
Kern Medical Center
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP