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

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ClinicalTrials.gov Identifier: NCT00613184
Recruitment Status : Unknown
Verified January 2008 by Kern Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2008
Last Update Posted : February 12, 2008
Sponsor:
Collaborators:
Information provided by:

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.


Condition or disease Intervention/treatment
Respiratory Syncytial Virus Human Metapneumovirus Influenza Bronchiolitis Pediatric Device: Nylon Flocked swab (Nasal secretion sampling)

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Study Start Date : November 2006
Primary Completion Date : January 2008
Estimated Study Completion Date : January 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Nylon Flocked swab Left Nasal Wash right
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: 2
Nylon Flocked swab R Nasal Wash L
Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
Experimental: 3
Nasal Wash Left Nylon Flocked swab Right
Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
Experimental: 4
Nasal Wash R Nylon flocked swab L
Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab


Outcome Measures

Primary Outcome Measures :
  1. Viral detection rate by PCR [ Time Frame: 0 not applicable ]

Eligibility Criteria

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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treating clinican ordered RSV antigen testing

Exclusion Criteria:

  • Refusal of consent
  • Age > 18 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613184


Sponsors and Collaborators
Kern Medical Center
Medical Diagnostic Laboratories, LLC
Copan Innovation Murrietta, CA
Investigators
Principal Investigator: Paul Walsh, MD Kern Medical Center & David Geffen School of Medicine UCLA
More Information

Responsible Party: Paul Walsh MB BCh FACEP, Department of Emergency Medicine, Kern Medical Center
ClinicalTrials.gov Identifier: NCT00613184     History of Changes
Other Study ID Numbers: kmc06037
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: February 12, 2008
Last Verified: January 2008

Keywords provided by Kern Medical Center:
Respiratory Syncytial virus
Bronchiolitis
Pediatric

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections