Respiratory Syncytial VirusNCT00613184
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
A study testing Nylon Flocked swab (Nasal secretion sampling) in people with Respiratory Syncytial Virus and Human Metapneumovirus, run by Kern Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Respiratory Syncytial Virus, Human Metapneumovirus, Influenza
- What is being tested?
- Nylon Flocked swab (Nasal secretion sampling)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Treating clinican ordered RSV antigen testing
Who cannot join
- Refusal of consent
- Age > 18 months
About this study
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.
.
Read the 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.
- Being tested
- Nylon Flocked swab (Nasal secretion sampling)
- Keywords
- Respiratory Syncytial virus, Bronchiolitis, Pediatric
- Medical subject headings
- Influenza, Human, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nylon Flocked swab (Nasal secretion sampling)Device
Nasal Aspirate Nylon Flocked swab
Nylon Flocked swab (Nasal secretion sampling)Device
Nylon flocked swab Nasal Wash
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nylon Flocked swab Left Nasal Wash right Receives: Device: Nylon Flocked swab (Nasal secretion sampling) |
| 2 | Experimental | Nylon Flocked swab R Nasal Wash L Receives: Device: Nylon Flocked swab (Nasal secretion sampling) |
| 3 | Experimental | Nasal Wash Left Nylon Flocked swab Right Receives: Device: Nylon Flocked swab (Nasal secretion sampling) |
| 4 | Experimental | Nasal Wash R Nylon flocked swab L Receives: Device: Nylon Flocked swab (Nasal secretion sampling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral detection rate by PCR
Measured: 0 not applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startNov 2006
- Primary completionJan 2008
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Diagnostic Laboratories, LLC, Copan Innovation Murrietta, CA
- Investigators
- Paul Walsh, MD, Principal investigator, Kern Medical Center & David Geffen School of Medicine UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613184
- Sponsor's protocol ID
- kmc06037
- Status last verified
- Jan 2008
- First submitted
- 29 Jan 2008
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
- ClinicalTrials.gov ID
- NCT00613184
- Acronym / sponsor ID
- kmc06037
- Keywords
- Respiratory Syncytial virus, Bronchiolitis, Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kern Medical CenterUniversity, hospital or other
- Collaborators
- Medical Diagnostic Laboratories, LLC, Copan Innovation Murrietta, CA
- Study start
- Nov 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (estimated)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Nylon Flocked swab (Nasal secretion sampling)Nylon Flocked swab Left Nasal Wash right |
| 2 | Experimental | Device: Nylon Flocked swab (Nasal secretion sampling)Nylon Flocked swab R Nasal Wash L |
| 3 | Experimental | Device: Nylon Flocked swab (Nasal secretion sampling)Nasal Wash Left Nylon Flocked swab Right |
| 4 | Experimental | Device: Nylon Flocked swab (Nasal secretion sampling)Nasal Wash R Nylon flocked swab L |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Treating clinican ordered RSV antigen testing
Key exclusion criteria (2 listed)
- Refusal of consent
- Age > 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nylon Flocked swab (Nasal secretion sampling)Nasal Aspirate Nylon Flocked swab | Device | 1, 2, 3, 4 |
| Nylon Flocked swab (Nasal secretion sampling)Nylon flocked swab Nasal Wash | Device | 1 |
Primary outcome
Viral detection rate by PCR
Time frame: 0 not applicable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Walsh, MD principal investigator
Kern Medical Center & David Geffen School of Medicine UCLA
Questions about this trial
What is this clinical trial studying?
A study testing Nylon Flocked swab (Nasal secretion sampling) in people with Respiratory Syncytial Virus and Human Metapneumovirus, run by Kern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral detection rate by PCR (time frame: 0 not applicable). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2008.