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

K

Kern Medical Center

Status

Unknown

Conditions

Human Metapneumovirus
Bronchiolitis
Respiratory Syncytial Virus
Influenza
Pediatric

Treatments

Device: Nylon Flocked swab (Nasal secretion sampling)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00613184
kmc06037

Details and patient eligibility

About

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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Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

Under 18 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Treating clinican ordered RSV antigen testing

Exclusion criteria

  • Refusal of consent
  • Age > 18 months

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

150 participants in 4 patient groups

1
Experimental group
Description:
Nylon Flocked swab Left Nasal Wash right
Treatment:
Device: Nylon Flocked swab (Nasal secretion sampling)
Device: Nylon Flocked swab (Nasal secretion sampling)
2
Experimental group
Description:
Nylon Flocked swab R Nasal Wash L
Treatment:
Device: Nylon Flocked swab (Nasal secretion sampling)
Device: Nylon Flocked swab (Nasal secretion sampling)
3
Experimental group
Description:
Nasal Wash Left Nylon Flocked swab Right
Treatment:
Device: Nylon Flocked swab (Nasal secretion sampling)
Device: Nylon Flocked swab (Nasal secretion sampling)
4
Experimental group
Description:
Nasal Wash R Nylon flocked swab L
Treatment:
Device: Nylon Flocked swab (Nasal secretion sampling)
Device: Nylon Flocked swab (Nasal secretion sampling)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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