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

Primary Purpose

Bronchiolitis, Bronchiolitis, Viral, RSV Infection

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nasal and Bronchial Sampling
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchiolitis

Eligibility Criteria

2 Weeks - 2 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Imperial College NHS Healthcare Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Emergency Department

Paediatric Wards

Paediatric Intensive Care

Health Controls

Controls in Paediatric Intensive Care

Arm Description

Babies with suspected respiratory tract infection (RTI) in the ED

Babies with diagnosed RSV infection admitted to paediatric wards

Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation

Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures

Babies without RSV infection but requiring mechanical ventilation in PICU

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
February 7, 2017
Last Updated
October 22, 2019
Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Pulmocide Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03062917
Brief Title
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
Acronym
RSV-SAM
Official Title
Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Babies and Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Pulmocide Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Bronchiolitis, Viral, RSV Infection, Respiratory Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emergency Department
Arm Type
Other
Arm Description
Babies with suspected respiratory tract infection (RTI) in the ED
Arm Title
Paediatric Wards
Arm Type
Other
Arm Description
Babies with diagnosed RSV infection admitted to paediatric wards
Arm Title
Paediatric Intensive Care
Arm Type
Other
Arm Description
Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation
Arm Title
Health Controls
Arm Type
Other
Arm Description
Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures
Arm Title
Controls in Paediatric Intensive Care
Arm Type
Other
Arm Description
Babies without RSV infection but requiring mechanical ventilation in PICU
Intervention Type
Diagnostic Test
Intervention Name(s)
Nasal and Bronchial Sampling
Intervention Description
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Primary Outcome Measure Information:
Title
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling
Description
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.
Time Frame
Throughout symptomatic respiratory infection, up to 1 month
Title
Accuracy of Nasosorption for Viral Load Measurement
Description
To determine the difference in accuracy of nasosorption compared to NPA by assessment of level of viral load (measured by qPCR).
Time Frame
Throughout symptomatic respiratory infection, up to 1 month
Title
Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate
Description
To determine the difference in accuracy of bronchosorption (BSAM) compared to tracheal aspirate (TA) by assessment of level of viral load (measured by qPCR).
Time Frame
Throughout symptomatic respiratory infection, up to 1 month
Secondary Outcome Measure Information:
Title
Immune Response
Description
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.
Time Frame
Throughout symptomatic respiratory infection, up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Imperial College NHS Healthcare Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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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Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis

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