Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis

Not Applicable

Completed

• Conditions: Bronchiolitis, Viral; Respiratory Failure; Bronchiolitis; RSV Infection
• Interventions: Diagnostic Test: Nasal and Bronchial Sampling

• Registration Number: NCT03062917
• Lead Sponsor: Imperial College Healthcare NHS Trust

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.

Study Timeline

• Study Start: 2015-10-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-24
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Results First Submitted: 2019-08-14
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-22
• Last Update Submitted: 2019-10-22
• Results First Posted: 2019-11-12
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Emergency Department	Nasal and Bronchial Sampling	Babies with suspected respiratory tract infection (RTI) in the ED
Paediatric Intensive Care	Nasal and Bronchial Sampling	Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation
Controls in Paediatric Intensive Care	Nasal and Bronchial Sampling	Babies without RSV infection but requiring mechanical ventilation in PICU
Paediatric Wards	Nasal and Bronchial Sampling	Babies with diagnosed RSV infection admitted to paediatric wards
Health Controls	Nasal and Bronchial Sampling	Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures

Primary Outcome Measures

Name	Time	Method
Accuracy of Nasosorption for Viral Load Measurement	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	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).
The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling	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.

Secondary Outcome Measures

Name	Time	Method
Immune Response	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.

Trial Locations

Locations (1)

Imperial College NHS Healthcare Trust; 🇬🇧 London, United Kingdom