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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Kern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Medical Diagnostic Laboratories, LLC
Copan Innovation Murrietta, CA
Information provided by:
Kern Medical Center
ClinicalTrials.gov Identifier:
NCT00613184
First received: January 29, 2008
Last updated: February 11, 2008
Last verified: January 2008
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses

Resource links provided by NLM:


Further study details as provided by Kern Medical Center:

Primary Outcome Measures:
  • Viral detection rate by PCR [ Time Frame: 0 not applicable ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2006
Estimated Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treating clinican ordered RSV antigen testing

Exclusion Criteria:

  • Refusal of consent
  • Age > 18 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: January 29, 2008
Last Updated: February 11, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bronchiolitis
Influenza, Human
Virus Diseases
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 17, 2014