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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Imperial College Healthcare NHS Trust
Sponsor:
Collaborator:
Pulmocide Ltd
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT03062917
First received: February 7, 2017
Last updated: February 20, 2017
Last verified: February 2017
  Purpose
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 Intervention
Bronchiolitis Bronchiolitis, Viral RSV Infection Respiratory Failure Diagnostic Test: Nasal and Bronchial Sampling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Babies and Children

Further study details as provided by Imperial College Healthcare NHS Trust:

Primary Outcome Measures:
  • Tolerability [ Time Frame: Through study completion, average 1 year ]
    To determine the difference in tolerability of SAM compared to NPA by assessment of acceptance by infants and families.

  • Accuracy [ Time Frame: Through study completion, average 1 year ]
    To determine the difference in accuracy of SAM compared to NPA by assessment of level of viral load and cytokines.

  • Sensitivity, specificity, quantitation Utility for RSV-A vs RSV-B using Viral load by qPCR [ Time Frame: Through study completion, average 1 year ]
    We shall assess Sensitivity, specificity, quantitation Utility for RSV-A vs RSV-B using Viral load by qPCR


Secondary Outcome Measures:
  • Immune Response [ Time Frame: Through study completion, average 1 year ]

    Establishing the use of nasal and bronchial sampling to measure the host immune response to RSV. We will determine cytokine and inflammatory mediator concentration in eluted fluid of SAM and compare with NPA.

    These techniques could then be applied to the study of drug pharmacokinetics for new therapeutics in future clinical studies.


  • Correlation of viral load using qPCR with clinical severity [ Time Frame: Through study completion, average 1 year ]

Estimated Enrollment: 80
Actual Study Start Date: October 2, 2015
Estimated Study Completion Date: April 30, 2017
Estimated Primary Completion Date: April 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03062917

Contacts
Contact: Simon Nadel 02078866077 s.nadel@imperial.nhs.uk

Locations
United Kingdom
Imperial College NHS Healthcare Trust Recruiting
London, United Kingdom, W2 1NY
Contact: Simon Nadel    02078866077    s.nadel@imperial.nhs.uk   
Principal Investigator: Simon Nadel         
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Pulmocide Ltd
  More Information

Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03062917     History of Changes
Other Study ID Numbers: 15/WM/0343
Study First Received: February 7, 2017
Last Updated: February 20, 2017
Individual Participant Data  
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Insufficiency
Bronchiolitis
Respiratory Syncytial Virus Infections
Bronchiolitis, Viral
Respiration Disorders
Respiratory Tract Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on June 23, 2017