Nasal samples from healthy children: towards prevention of pneumonia
| ISRCTN | ISRCTN76456378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76456378 |
| Protocol serial number | 36936 |
| Sponsor | Liverpool School of Tropical Medicine |
| Funders | Liverpool School of Tropical Medicine, Medical Research Council |
- Submission date
- 29/01/2018
- Registration date
- 12/02/2018
- Last edited
- 24/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Streptococcus pneumoniae, is a type of bacteria that is an important cause of morbidity and mortality in children worldwide. At the same time healthy people often have this bacteria in the upper airway (nasopharynx) without any sign of disease (colonised) which is the main source for transmission to other people. The current pneumococcal conjugate vaccines (PCV) does not protect against all types of this group of bacteria. Novel vaccines aim to provide broader protection against pneumococcus and are currently being developed. To test these new vaccines in future we need to learn more about how the body responds to this bacteria. It has been observed in adults who are colonised for research purposes (experimentally) with this bacteria that a specific immune cell 'monocyte' is present in the airway that correlates with protection against carriage of this bacteria. It is important to understanding whether this immune mechanisms control carriage in children in order to test vaccines. The aim of this study is determine whether nasal monocytes control pneumococcus by assessing the nasal immune responses to pneumococcus in children.
Who can participate?
Children aged 1 to 5 years old who are waiting to undergo a minor procedure requiring general anesthesia.
What does the study involve?
Participants undergo their planned procedure. They have cells from their nose collected, as well as the nasal lining fluid and have a swab taken of the nose to assess bacteria presence. A throat swab is also collected. Blood samples are collected. There is no further follow up.
What are the possible benefits and risks of participating?
There are no direct benefits with participating. This study collects nasal samples in a non-invasive manner. A possible risk for participants related to the nasal scrape is a slight amount of blood due to scratching of the mucosal lining. In over 1000 such samples that we have collected from adult volunteers, we have not had any serious events related to sample collection. We have collected blood cultures in 20 adults that were sampled during five visits to see if this led to transient bacteremia. We did not detect any bacteremia following sample collection. In addition, we are collecting a blood sample, which at the discretion of the anaesthesist, can be collected from the line used for administration of anaesthetics. Samples will be collected by experienced members of the clinical team. Study nurses, as well as researchers at LSTM, are working according to SOPs taking institutional risk assessments into accounts with regards to working with biological samples.
Where is the study run from?
Alder Hey Children’s Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2017 to September 2020
Who is funding the study?
1. Liverpool School of Tropical Medicine (UK)
2. Medical Research Council (UK)
Who is the main contact?
Mr Simon Jochems (Public)
Contact information
Scientific
Liverpool Life Sciences Accelerator
1 Daulby Street
Liverpool
L7 8XZ
United Kingdom
| Phone | +44 151 702 9439 |
|---|---|
| Andrea.collins@lstmed.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | ; Observational; Design type: Cross-sectional |
| Secondary study design | Cross sectional study |
| Participant information sheet | ISRCTN76456378_PIS_ v10.docx |
| Scientific title | SNOT: Sampling the Nose Of Toddlers and Young Children |
| Study acronym | SNOT |
| Study objectives | The aim of this study is determine whether nasal monocytes control pneumococcus by assessing the nasal immune responses to pneumococcus in children. |
| Ethics approval(s) | NHS REC East Liverpool, 16/01/2018, ref: 17/NW/0663 |
| Health condition(s) or problem(s) studied | Streptococcus pneumoniae colonisation |
| Intervention | Children aged 1-5 years are recruited to this study as UK carriage rates peak at 2 years and start to decline at 5 years. Children without a current infection awaiting a minor procedure that requires general anesthesia at Alder Hey Children’s hospital are recruited. All samples are collected under general anesthesia to reduce potential discomfort and to not have to immobilize the participant during sample collection. All sample collection methods have been previously used in paediatric settings. Nasal cells are collected by gently scraping the inferior turbinate using curettes. Nasal lining fluid is collected using nasosorption devices (synthetic filter paper that adsorbs cytokines). A bacterial nasopharyngeal (NP) swab is collected to assess bacterial presence. An oropharyngeal throat swab is collected to measure viral presence. Up to 3mL of venous blood is collected to measure humoral and cellular immune responses in blood. |
| Intervention type | Other |
| Primary outcome measure(s) |
The frequency of monocytes in nasal microbiopsies of children carrying pneumococcus and those who don’t is measured by flow cytometry at the study visit. |
| Key secondary outcome measure(s) |
1. Pneumococcal carriage is measured using lyta qPCR from nasopharyngeal swabs at study visit |
| Completion date | 01/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Children aged 1-5 years 2. Parent with fluent spoken English - to ensure a comprehensive understanding of the research project and the proposed involvement 3. Capacity of parent to give informed consent 4. Awaiting minor procedure requiring general anesthesia |
| Key exclusion criteria | Exclusion criteria: 1. Taking daily medications that may affect the immune system e.g. systemic steroids or systemic corticosteroids. 2. Having received antibiotics in the preceding 28 days 3. History of respiratory infections requiring hospitalization 4. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase. 5. Disease associated with altered immunity 6. Surgery related to infection 7. Asthma 8. Current severe acute respiratory infection |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 01/09/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Liverpool
L14 5AB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version v10 | 01/04/2019 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN76456378_PIS_ v10.docx
- Uploaded 01/04/2019
Editorial Notes
24/04/2019: Dr Andrea Collins has replaced Simon Jochems as the trial contact.
01/04/2019: The participant information sheet has been uploaded.
27/03/2019: The condition has been changed from "Specialty: Children, Primary sub-specialty: Allergy, Infection and Immunity ; UKCRC code/ Disease: Infection/ Bacterial, viral and other infectious agents" to "Streptococcus pneumoniae colonisation" following a request from the NIHR.
