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| Name | Class |
|---|---|
| Pulmocide Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Department | Other | Babies with suspected respiratory tract infection (RTI) in the ED |
|
| Paediatric Wards | Other | Babies with diagnosed RSV infection admitted to paediatric wards |
|
| Paediatric Intensive Care | Other | Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation |
|
| Health Controls | Other | Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures |
|
| Controls in Paediatric Intensive Care | Other | Babies without RSV infection but requiring mechanical ventilation in PICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal and Bronchial Sampling | Diagnostic Test | Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout symptomatic respiratory infection, up to 1 month |
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Group 1 and Group 2
Inclusion Criteria
OR • Documented RSV infection, admitted to the paediatric wards at St Mary's Hospital.
Exclusion Criteria
Group 3
Inclusion criteria
Exclusion criteria
Control Group 1 Inclusion criteria
• Babies, aged 2 weeks-24 months, attending routine outpatient appointments or undergoing elective surgical procedures.
Exclusion criteria
Control Group 2
Inclusion criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College NHS Healthcare Trust | London | W2 1NY | United Kingdom |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Emergency Department | Babies with suspected respiratory tract infection (RTI) in the ED Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| FG001 | Paediatric Wards | Babies with diagnosed RSV infection admitted to paediatric wards Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| FG002 | Paediatric Intensive Care | Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| FG003 | Health Controls | Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| FG004 | Controls in Paediatric Intensive Care | Babies without RSV infection but requiring mechanical ventilation in PICU Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Controls in paediatric intensive care were sought but non recruited
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| ID | Title | Description |
|---|---|---|
| BG000 | Emergency Department | Babies with suspected respiratory tract infection (RTI) in the ED Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| BG001 | Paediatric Wards |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Parents asked at each sampling timepoint on willingness to continue with respiratory sampling, as either: 1) both nasosorption and NPA, 2) just nasosorption, 3) just NPA, 4) discontinue sampling. This analysis includes all non-sedated hospitalised participants as sedation would influence the tolerability of sampling as perceived by parents/carers. | Posted | Number | Sampling visits | Throughout symptomatic respiratory infection, up to 1 month | Number of individual sampling visits | Number of individual sampling visits |
|
Throughout participant hospitalisation, to a maximum of 6 months after the end of sampling
As per clinicaltrials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emergency Department | Babies with suspected respiratory tract infection (RTI) in the ED Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study PI Simon Nadel | Imperial College NHS trust | 02033126202 | s.nadel@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2016 | Aug 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001990 | Bronchiolitis, Viral |
| D018357 | Respiratory Syncytial Virus Infections |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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Babies with diagnosed RSV infection admitted to paediatric wards Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| BG002 | Paediatric Intensive Care | Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| BG003 | Health Controls | Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| BG004 | Controls in Paediatric Intensive Care | Babies without RSV infection but requiring mechanical ventilation in PICU Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. |
| BG005 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
None sedated participants recruited from general paediatric wards
| OG001 | Emergency Department | Non-ventilated participants recruited from the emergency department |
|
|
| Primary | 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). | Spearman R score correlation between RSV viral load as measured by nasosorption and NPA. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group. | Posted | Number | Spearman R score | Throughout symptomatic respiratory infection, up to 1 month | Number matched RSV+ nasosorption and NPA | Number matched RSV+ nasosorption and NPA |
|
|
|
| Secondary | 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. | Spearman R score correlation of Interferon-gamma levels in matched nasosorption and NPA samples from any participant. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group. | Posted | Number | Spearman R score | Throughout symptomatic respiratory infection, up to 1 month | Number matched nasosorption and NPA | Number matched nasosorption and NPA |
|
|
|
| Primary | 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). | Spearman R score correlation between RSV viral load as measured by bronchosorption and tracheal aspiration. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group. | Posted | Number | Spearman R score | Throughout symptomatic respiratory infection, up to 1 month | Number matched RSV+ BSAM and TA | Number matched RSV+ BSAM and TA |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Paediatric Wards | Babies with diagnosed RSV infection admitted to paediatric wards Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | Paediatric Intensive Care | Babies with diagnosed severe RSV infection in PICU requiring mechanical ventilation Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. | 0 | 49 | 0 | 49 | 0 | 49 |
| EG003 | Health Controls | Babies without respiratory symptoms, attending routine outpatient appointments or undergoing elective surgical procedures Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Controls in Paediatric Intensive Care | Babies without RSV infection but requiring mechanical ventilation in PICU Nasal and Bronchial Sampling: Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D014777 | Virus Diseases |
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D012120 | Respiration Disorders |