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

• Sponsor: Kern Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00613184
• Collaborator: Medical Diagnostic Laboratories, LLC (Industry), Copan Innovation Murrietta, CA (Other)
• Enrollment: 150
• Arms: 4
• Duration (Months): 14

Study Details

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.

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Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus; Human Metapneumovirus; Influenza; Bronchiolitis; Pediatric	Device: Nylon Flocked swab (Nasal secretion sampling); Device: Nylon Flocked swab (Nasal secretion sampling)	N/A

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
• Anticipated 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: Nov 1, 2006
• Actual Primary Completion Date: Jan 1, 2008
• Anticipated Study Completion Date: Jan 1, 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 [0 not applicable]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Treating clinican ordered RSV antigen testing

Exclusion Criteria:

• Refusal of consent

• Age > 18 months

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00613184
• Other Study ID Numbers: kmc06037
• First Posted: Feb 12, 2008
• Last Update Posted: Feb 12, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Respiratory Syncytial virus; Bronchiolitis; Pediatric
• Additional relevant MeSH terms: Bronchiolitis

Study Results

No Results Posted as of Feb 12, 2008