BronchiolitisRSV-SAMNCT03062917
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
A study testing Nasal and Bronchial Sampling in people with Bronchiolitis and Bronchiolitis, Viral, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This study will compare the novel methods of NS and BS with the standard technique of nasophayngeal aspiration (NPA) and routine ETT suction. We shall assess the samples for diagnosis of RSV, viral load and immune responses in the airways of babies with RSV infection. Read more about this study
- Who is it for?
- Ages 2 weeks to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis, Bronchiolitis, Viral, RSV Infection
- What is being tested?
- Nasal and Bronchial Sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 weeks to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 2 weeks-24 months
- Presentation to the Emergency Department with any upper respiratory tract infection (URTI) in the RSV season (Oct-March).
- OR • Documented RSV infection, admitted to the paediatric wards at St Mary's Hospital.
- Hospitalised Infants admitted to the PICU at St. Mary's Hospital, aged 2 weeks-24 months with documented RSV infection (by rapid test and/or PCR).
- Infants of weight >2kg.
- On a conventional ventilator with an Endotracheal Tube (ETT) of >3.0mmm diameter
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- Infants aged 2 weeks-24 months.
- Infants ventilated on the PICU for any condition
- Confirmed RSV negative by PCR of respiratory tract samples
Who cannot join
- Any local or systemic factor that would influence the safety of nasal sampling.
- Bilateral indwelling nasal catheters or local nasal pathology preventing access for nasal sampling.
- Bleeding disorders.
- The baby is taking part in another interventional study.
- The parents or guardians not able to sign the informed consent from due to limited English or comprehension despite the use of independent interpreter services.
- Limited life expectancy of the baby,
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- Group 3
- Any local or systemic factor that would influence the safety of nasal sampling.
- Bilateral nasal catheters or local nasal pathology preventing access for nasal sampling.
- The baby is taking part in another interventional study.
- Prematurity - corrected gestational age <36 weeks, weight <2kg
- Significant hypoxia or instability precluding ventilator disconnection
- ETT < 3mm internal diameter
- Transcutaneous oxygen saturation of <95% on 60% oxygen
- Risk of bleeding
- Pneumothorax
- Infants receiving oral corticosteroid therapy at any time in past month
- Parents or guardians not able to sign informed consent from due to limited English or understanding despite the use of independent interpreter services.
- Limited life expectancy or a decision to limit management,
- Control Group 1 Inclusion criteria
- Babies, aged 2 weeks-24 months, attending routine outpatient appointments or undergoing elective surgical procedures.
- Any respiratory symptoms
- All other exclusion are the same as Groups 1 and 2
- Control Group 2
- All exclusions are the same as Group 3
- In addition - any concern about raised intracranial pressure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College NHS Healthcare Trust
London, W2 1NY
About this study
Official title: Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Babies and Children
This study will compare the novel methods of NS and BS with the standard technique of nasophayngeal aspiration (NPA) and routine ETT suction. We shall assess the samples for diagnosis of RSV, viral load and immune responses in the airways of babies with RSV infection. We shall also assess the genetics of babies included in this study, to see if they may be vulnerable to RSV infection.
Read the detailed description
In conjunction with a specialist medical device manufacturing company (Hunt Developments (Midhurst, West Sussex) we have produced novel nasosorption and bronchosorption kits that have CE marking. Both nasosorption and bronchosorption methods use synthetic absorptive matrix (SAM) strips: that look and feel like blotting paper, and will be placed onto the mucosal surface. These are comfortable to use and can be used at frequent intervals over extended periods of time. This non-invasive technique is ideal for infants and children, and it is possible to obtain neat mucosal lining fluid (MLF) even from normal healthy noses. The eluates contain cytokines and chemokines at high detectable levels on multiplex immunoassay.
We would like to use these SAMs to take MLF samples from the nasal and bronchial mucosal surfaces to see if these novel techniques can overcome the problems with current sampling methods. We plan to use these absorption techniques to measure RSV viral load. We also aim to look at the immune response in terms of the anti-viral interferon response (IFN-γ, IFN-λ, IFN-α2a, IP10, ITAC). In therapeutic studies in the future, it may be possible to document levels of drug (pharmacokinetics) in nasal MLF.
- Being tested
- Nasal and Bronchial Sampling
- Medical subject headings
- Bronchiolitis, Bronchiolitis, Viral, Respiratory Syncytial Virus Infections, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal and Bronchial SamplingDiagnostic test
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Department | Other | Babies with suspected respiratory tract infection (RTI) in the ED Receives: Diagnostic Test: Nasal and Bronchial Sampling |
| Paediatric Wards | Other | Babies with diagnosed RSV infection admitted to paediatric wards Receives: Diagnostic Test: Nasal and Bronchial Sampling |
| Paediatric Intensive Care | Other | Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation Receives: Diagnostic Test: Nasal and Bronchial Sampling |
| Health Controls | Other | Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures Receives: Diagnostic Test: Nasal and Bronchial Sampling |
| Controls in Paediatric Intensive Care | Other | Babies without RSV infection but requiring mechanical ventilation in PICU Receives: Diagnostic Test: Nasal and Bronchial Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling
To determine the difference in tolerability of nasosorption compared to NPA by assessment of acceptance by infants and families. Samples were collected from participants up to twice daily throughout study involvement, as such each participant could have >1 sampling visits.
Measured: Throughout symptomatic respiratory infection, up to 1 month
Accuracy of Nasosorption for Viral Load Measurement
To determine the difference in accuracy of nasosorption compared to NPA by assessment of level of viral load (measured by qPCR).
Measured: Throughout symptomatic respiratory infection, up to 1 month
Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate
To determine the difference in accuracy of bronchosorption (BSAM) compared to tracheal aspirate (TA) by assessment of level of viral load (measured by qPCR).
Measured: Throughout symptomatic respiratory infection, up to 1 month
Secondary outcomes (1)
Immune Response
Establishing the use of nasal and bronchial sampling to measure the host immune response to RSV. We will determine cytokine and inflammatory mediator concentrations by immunoassay of eluted fluid from nasosorption and compare with NPA.
Measured: Throughout symptomatic respiratory infection, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start2 Oct 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BronchiolitisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pulmocide Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062917
- Sponsor's protocol ID
- 15/WM/0343
- Acronym
- RSV-SAM
- Status last verified
- Oct 2019
- First submitted
- 7 Feb 2017
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants consented that blood or nasal samples taken during this study can be used in the future for any ethically-approved studies.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Babies and Children
- ClinicalTrials.gov ID
- NCT03062917
- Acronym / sponsor ID
- RSV-SAM / 15/WM/0343
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Pulmocide Ltd
- Study start
- 2 Oct 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 12 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the novel methods of NS and BS with the standard technique of nasophayngeal aspiration (NPA) and routine ETT suction. We shall assess the samples for diagnosis of RSV, viral load and immune responses in the airways of babies with RSV infection. We shall also assess the genetics of babies included in this study, to see if they may be vulnerable to RSV infection.
Detailed description
In conjunction with a specialist medical device manufacturing company (Hunt Developments (Midhurst, West Sussex) we have produced novel nasosorption and bronchosorption kits that have CE marking. Both nasosorption and bronchosorption methods use synthetic absorptive matrix (SAM) strips: that look and feel like blotting paper, and will be placed onto the mucosal surface. These are comfortable to use and can be used at frequent intervals over extended periods of time. This non-invasive technique is ideal for infants and children, and it is possible to obtain neat mucosal lining fluid (MLF) even from normal healthy noses. The eluates contain cytokines and chemokines at high detectable levels on multiplex immunoassay.
We would like to use these SAMs to take MLF samples from the nasal and bronchial mucosal surfaces to see if these novel techniques can overcome the problems with current sampling methods. We plan to use these absorption techniques to measure RSV viral load. We also aim to look at the immune response in terms of the anti-viral interferon response (IFN-γ, IFN-λ, IFN-α2a, IP10, ITAC). In therapeutic studies in the future, it may be possible to document levels of drug (pharmacokinetics) in nasal MLF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Emergency Department | Other | Diagnostic Test: Nasal and Bronchial SamplingBabies with suspected respiratory tract infection (RTI) in the ED |
| Paediatric Wards | Other | Diagnostic Test: Nasal and Bronchial SamplingBabies with diagnosed RSV infection admitted to paediatric wards |
| Paediatric Intensive Care | Other | Diagnostic Test: Nasal and Bronchial SamplingBabies with diagnosed severe RSV infection in PICU requiring mechanical ventilation |
| Health Controls | Other | Diagnostic Test: Nasal and Bronchial SamplingBabies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures |
| Controls in Paediatric Intensive Care | Other | Diagnostic Test: Nasal and Bronchial SamplingBabies without RSV infection but requiring mechanical ventilation in PICU |
Who may qualify
- Ages
- 2 weeks to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Infants aged 2 weeks-24 months
- Presentation to the Emergency Department with any upper respiratory tract infection (URTI) in the RSV season (Oct-March).
- OR • Documented RSV infection, admitted to the paediatric wards at St Mary's Hospital.
- Hospitalised Infants admitted to the PICU at St. Mary's Hospital, aged 2 weeks-24 months with documented RSV infection (by rapid test and/or PCR).
- Infants of weight >2kg.
Key exclusion criteria (26 listed)
- Any local or systemic factor that would influence the safety of nasal sampling.
- Bilateral indwelling nasal catheters or local nasal pathology preventing access for nasal sampling.
- Bleeding disorders.
- The baby is taking part in another interventional study.
- The parents or guardians not able to sign the informed consent from due to limited English or comprehension despite the use of independent interpreter services.
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 |
|---|---|---|
| Nasal and Bronchial SamplingNasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. | Diagnostic test | Controls in Paediatric Intensive Care, Emergency Department, Health Controls, Paediatric Intensive Care, Paediatric Wards |
Primary outcome
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling
Time frame: Throughout symptomatic respiratory infection, up to 1 month
To determine the difference in tolerability of nasosorption compared to NPA by assessment of acceptance by infants and families. Samples were collected from participants up to twice daily throughout study involvement, as such each participant could have >1 sampling visits.
Accuracy of Nasosorption for Viral Load Measurement
Time frame: Throughout symptomatic respiratory infection, up to 1 month
To determine the difference in accuracy of nasosorption compared to NPA by assessment of level of viral load (measured by qPCR).
Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate
Time frame: Throughout symptomatic respiratory infection, up to 1 month
To determine the difference in accuracy of bronchosorption (BSAM) compared to tracheal aspirate (TA) by assessment of level of viral load (measured by qPCR).
1 secondary outcome
Immune Response
Time frame: Throughout symptomatic respiratory infection, up to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Participants consented that blood or nasal samples taken during this study can be used in the future for any ethically-approved studies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal and Bronchial Sampling in people with Bronchiolitis and Bronchiolitis, Viral, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 9 inclusion and 26 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: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling (time frame: Throughout symptomatic respiratory infection, up to 1 month). The study lists 3 primary outcomes in all. 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 Nov 2019.