Overview

This trial is active, not recruiting.

Conditions respiratory syncytial virus, human metapneumovirus, influenza, bronchiolitis, pediatric
Treatments nylon flocked swab (nasal secretion sampling)
Sponsor Kern Medical Center
Collaborator Medical Diagnostic Laboratories, LLC
Start date November 2006
End date January 2008
Trial size 150 participants
Trial identifier NCT00613184, kmc06037

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.

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United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Nylon Flocked swab Left Nasal Wash right
nylon flocked swab (nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
nylon flocked swab (nasal secretion sampling)
Nylon flocked swab Nasal Wash
(Experimental)
Nylon Flocked swab R Nasal Wash L
nylon flocked swab (nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
(Experimental)
Nasal Wash Left Nylon Flocked swab Right
nylon flocked swab (nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
(Experimental)
Nasal Wash R Nylon flocked swab L
nylon flocked swab (nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab

Primary Outcomes

Measure
Viral detection rate by PCR
time frame: 0 not applicable

Eligibility Criteria

Male or female participants up to 18 months old.

Inclusion Criteria: - Treating clinican ordered RSV antigen testing Exclusion Criteria: - Refusal of consent - Age > 18 months

Additional Information

Official title Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
Principal investigator Paul Walsh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Kern Medical Center.