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Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis (RSV-SAM)

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ClinicalTrials.gov Identifier: NCT03062917
Recruitment Status : Completed
First Posted : February 24, 2017
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Pulmocide Ltd
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

Study Description
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Brief 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. We shall also assess the genetics of babies included in this study, to see if they may be vulnerable to RSV infection.

Condition or disease Intervention/treatment Phase
Bronchiolitis Bronchiolitis, Viral RSV Infection Respiratory Failure Diagnostic Test: Nasal and Bronchial Sampling Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Babies and Children
Actual Study Start Date : October 2, 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Emergency Department
Babies with suspected respiratory tract infection (RTI) in the ED
 Diagnostic Test: Nasal and Bronchial Sampling
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Paediatric Wards
Babies with diagnosed RSV infection admitted to paediatric wards
 Diagnostic Test: Nasal and Bronchial Sampling
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Paediatric Intensive Care
Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation
 Diagnostic Test: Nasal and Bronchial Sampling
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Health Controls
Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures
 Diagnostic Test: Nasal and Bronchial Sampling
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Controls in Paediatric Intensive Care
Babies without RSV infection but requiring mechanical ventilation in PICU
 Diagnostic Test: Nasal and Bronchial Sampling
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Immune Response [ Time Frame: Throughout symptomatic respiratory infection, up to 1 month ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group 1 and Group 2

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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,

Group 3

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Exclusion criteria

  • Any respiratory symptoms
  • All other exclusion are the same as Groups 1 and 2

Control Group 2

Inclusion criteria

  • Infants aged 2 weeks-24 months.
  • Infants ventilated on the PICU for any condition
  • Confirmed RSV negative by PCR of respiratory tract samples

Exclusion Criteria

  • All exclusions are the same as Group 3
  • In addition - any concern about raised intracranial pressure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062917


Locations
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United Kingdom
Imperial College NHS Healthcare Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Pulmocide Ltd
  Study Documents (Full-Text)

Documents provided by Imperial College Healthcare NHS Trust:
Study Protocol and Statistical Analysis Plan  [PDF] November 17, 2016

More Information
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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03062917    
Other Study ID Numbers: 15/WM/0343
First Posted: February 24, 2017    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis
Respiratory Syncytial Virus Infections
Bronchiolitis, Viral
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Bronchitis
Respiratory Tract Infections
Infections
 Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases