Pneumococcal InfectionsNoseSpnElderlyNCT06998251
In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)
An observational study of Pneumococcal Infections and Respiratory Syncytial Virus (RSV) Infection, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The NoseSpn-Elderly study aims at characterizing the immune response in the upper respiratory tract in adults aged 60 and over diagnosed with a pneumonia due to a Streptococcus pneumoniae (Spn) infection. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections, Respiratory Syncytial Virus (RSV) Infection, Influenza Infection
- How many people
- 280 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Dec 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 and group 2 participants will be recruited among patients hospitalized or consulting the emergencies at the Geneva University Hospitals (HUG). Group 3 participants will be recruited among participants of other HUG studies involving healthy adults as well as from the general population.
Who may be able to join
- Aged 60-85 years
- Able to provide informed consent either independently or by a legal representative
- Group 1 (Spn pneumonia patients): clinical and/or radiological signs of pneumonia
- Group 1 (Spn pneumonia patients): positive Spn urinary antigen and/or blood culture and/or positive sputum test.
- Group 2 (viral respiratory infection patients): clinical signs of a respiratory infection
- Group 2 (viral respiratory infection patients): positive test for influenza or RSV
- Group 3 (asymptomatic Spn-carriers): healthy without clinical signs of infection and no lower respiratory symptoms within the last month.
Who cannot join
- Immunosuppression,
- Use of inhalation and/or nasal steroids the last month
- Intubation or under invasive mechanical ventilation
- Long-term antibiotic treatment prior to disease onset
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1205
Jennifer Villers, PhD, +41795538886, jennifer.villers@hug.ch
Virginie Prendki, MD
About this study
The NoseSpn-Elderly study aims at characterizing the immune response in the upper respiratory tract in adults aged 60 and over diagnosed with a pneumonia due to a Streptococcus pneumoniae (Spn) infection. The immune response during the acute phase of the infection and after recovery will be compared to the immune response of asymptomatic Spn carriers as well as to the immune response of patients diagnosed with a viral respiratory infection (flu or respiratory syncytial virus (RSV)).
The primary objective of this observational study is to quantify the inflammatory response in the nasal cavity and to correlate it with bacterial/viral load and with clinical parameters. The study also aims to compare the inflammatory response measured in the nose to that measured in the blood.
Participants will have two study visits including a blood draw, several nasal samplings (nasal lining fluid and nasal cells) and a saliva sampling, one within 72 hours of their hospital admission and another one month later. Nasal lining fluid and saliva will be obtained every two or three days until discharge from the hospital or resolution of symptoms. During those visits, questions regarding symptoms will be asked.
- Medical subject headings
- Pneumococcal Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spn patients | Patients hospitalized with community-acquired pneumonia due to a Streptococcus pneumoniae infection | |
| Flu/RSV patients | Patients hospitalized with flu-like symptoms and a laboratory-confirmed influenza or RSV infection | |
| Asymptomatic Spn carriers | Healthy people screened for asymptomatic carriage of Streptococcus pneumoniae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay
Measured: 1 month
Secondary outcomes (20)
Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry
Measured: 1 month
Antibody titers in nasal cavity and blood by antigen-specific ELISA
Measured: 1 month
Bacterial load and viral load in nasal cavity by specific qPCR assay
Measured: 1 month
Levels of serum cytokines by multiplex assay
Measured: 1 month
Clinical outcome measure 1: pneumonia diagnostic
Probability of diagnosis of pneumonia (on a 3-Likert scale: low, intermediate and high level of probability)
Measured: 1 month
Clinical outcome measure 2: CURB65 severity score
Measured: 1 month
Clinical outcome measure 3: nature and severity of symptoms (CAP score)
Measured: 1 month
Clinical outcome measure 4: number of days with fever
Measured: 1 month
Clinical outcome measure 5: number of days with oxygen
Measured: 1 month
Clinical outcome measure 6: highest FiO2
Measured: 1 month
Clinical outcome measure 7: cardiac complication
Measured: 1 month
Clinical outcome measure 8: secondary bacterial infection
Only for group 2 patients (viral infection)
Measured: 1 month
Clinical outcome measure 9: transfer to ICU or IMCU
Measured: 1 month
Clinical outcome measure 10: length of stay in intensive care
Measured: 1 month
Clinical outcome measure 11: intubation or mechanical ventilation
Measured: 1 month
Clinical outcome measure 12: transfer to rehabilitation or institutionalization
Measured: 1 month
Clinical outcome measure 13: mortality
Measured: 1 month
Clinical outcome measure 14: rehospitalization
Measured: 1 month
Clinical outcome measure 15: medical consultation for a respiratory disease
Measured: 1 month
Clinical outcome measure 16: new prescription of antibiotics or corticosteroids
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start3 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Arnaud Didierlaurent, University of Geneva, Switzerland
- Investigators
- Arnaud Didierlaurent, PhD, Principal investigator, University of Geneva, SwitzerlandVirginie Prendki, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998251
- Sponsor's protocol ID
- 2024-01135
- Acronym
- NoseSpnElderly
- Status last verified
- May 2025
- First submitted
- 28 Mar 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)
- ClinicalTrials.gov ID
- NCT06998251
- Acronym / sponsor ID
- NoseSpnElderly / 2024-01135
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NoseSpn-Elderly study aims at characterizing the immune response in the upper respiratory tract in adults aged 60 and over diagnosed with a pneumonia due to a Streptococcus pneumoniae (Spn) infection. The immune response during the acute phase of the infection and after recovery will be compared to the immune response of asymptomatic Spn carriers as well as to the immune response of patients diagnosed with a viral respiratory infection (flu or respiratory syncytial virus (RSV)).
The primary objective of this observational study is to quantify the inflammatory response in the nasal cavity and to correlate it with bacterial/viral load and with clinical parameters. The study also aims to compare the inflammatory response measured in the nose to that measured in the blood.
Participants will have two study visits including a blood draw, several nasal samplings (nasal lining fluid and nasal cells) and a saliva sampling, one within 72 hours of their hospital admission and another one month later. Nasal lining fluid and saliva will be obtained every two or three days until discharge from the hospital or resolution of symptoms. During those visits, questions regarding symptoms will be asked.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spn patients | – | –Patients hospitalized with community-acquired pneumonia due to a Streptococcus pneumoniae infection |
| Flu/RSV patients | – | –Patients hospitalized with flu-like symptoms and a laboratory-confirmed influenza or RSV infection |
| Asymptomatic Spn carriers | – | –Healthy people screened for asymptomatic carriage of Streptococcus pneumoniae |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 and group 2 participants will be recruited among patients hospitalized or consulting the emergencies at the Geneva University Hospitals (HUG). Group 3 participants will be recruited among participants of other HUG studies involving healthy adults as well as from the general population.
Key inclusion criteria (7 listed)
- Aged 60-85 years
- Able to provide informed consent either independently or by a legal representative
- Group 1 (Spn pneumonia patients): clinical and/or radiological signs of pneumonia
- Group 1 (Spn pneumonia patients): positive Spn urinary antigen and/or blood culture and/or positive sputum test.
- Group 2 (viral respiratory infection patients): clinical signs of a respiratory infection
Key exclusion criteria (4 listed)
- Immunosuppression,
- Use of inhalation and/or nasal steroids the last month
- Intubation or under invasive mechanical ventilation
- Long-term antibiotic treatment prior to disease onset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay
Time frame: 1 month
20 secondary outcomes
Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry
Time frame: 1 month
Antibody titers in nasal cavity and blood by antigen-specific ELISA
Time frame: 1 month
Bacterial load and viral load in nasal cavity by specific qPCR assay
Time frame: 1 month
Levels of serum cytokines by multiplex assay
Time frame: 1 month
Clinical outcome measure 1: pneumonia diagnostic
Time frame: 1 month
Clinical outcome measure 2: CURB65 severity score
Time frame: 1 month
Clinical outcome measure 3: nature and severity of symptoms (CAP score)
Time frame: 1 month
Clinical outcome measure 4: number of days with fever
Time frame: 1 month
Clinical outcome measure 5: number of days with oxygen
Time frame: 1 month
Clinical outcome measure 6: highest FiO2
Time frame: 1 month
Clinical outcome measure 7: cardiac complication
Time frame: 1 month
Clinical outcome measure 8: secondary bacterial infection
Time frame: 1 month
Clinical outcome measure 9: transfer to ICU or IMCU
Time frame: 1 month
Clinical outcome measure 10: length of stay in intensive care
Time frame: 1 month
Clinical outcome measure 11: intubation or mechanical ventilation
Time frame: 1 month
Clinical outcome measure 12: transfer to rehabilitation or institutionalization
Time frame: 1 month
Clinical outcome measure 13: mortality
Time frame: 1 month
Clinical outcome measure 14: rehospitalization
Time frame: 1 month
Clinical outcome measure 15: medical consultation for a respiratory disease
Time frame: 1 month
Clinical outcome measure 16: new prescription of antibiotics or corticosteroids
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud Didierlaurent, PhD principal investigator
University of Geneva, Switzerland
Virginie Prendki, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections and Respiratory Syncytial Virus (RSV) Infection, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Villers, PhD (+41 79 553 88 86, jennifer.villers@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.