Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
RSV-SAM
Validation of Nasal and Bronchial Absorption Sampling Methods for the Assessment of RSV Bronchiolitis in Babies and Children
1 other identifier
interventional
152
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2015
CompletedFirst Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedResults Posted
Study results publicly available
November 12, 2019
CompletedNovember 12, 2019
October 1, 2019
2.7 years
February 7, 2017
August 14, 2019
October 22, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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).
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).
Throughout symptomatic respiratory infection, up to 1 month
Secondary Outcomes (1)
Immune Response
Throughout symptomatic respiratory infection, up to 1 month
Study Arms (5)
Emergency Department
OTHERBabies with suspected respiratory tract infection (RTI) in the ED
Paediatric Wards
OTHERBabies with diagnosed RSV infection admitted to paediatric wards
Paediatric Intensive Care
OTHERBabies with diagnosed severe RSV infection in PICU requiring mechanical ventilation
Health Controls
OTHERBabies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures
Controls in Paediatric Intensive Care
OTHERBabies without RSV infection but requiring mechanical ventilation in PICU
Interventions
Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Healthcare NHS Trustlead
- Pulmocide Ltdcollaborator
Study Sites (1)
Imperial College NHS Healthcare Trust
London, W2 1NY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study PI Simon Nadel
- Organization
- Imperial College NHS trust
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 24, 2017
Study Start
October 2, 2015
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
November 12, 2019
Results First Posted
November 12, 2019
Record last verified: 2019-10