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RecruitingNCT06998251NoseSpnElderlyUpdated May 31, 2025

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 in Pneumococcal Infections, Respiratory Syncytial Virus (RSV) Infection and Influenza Infection, sponsored by University Hospital, Geneva. Recruiting at 1 site in Switzerland. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by University Hospital, Geneva · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
60 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pneumococcal Infections
  • Respiratory Syncytial Virus (RSV) Infection
  • Influenza Infection
03

In context

Pneumococcal Infections

298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.

This study's planned enrollment of 280 is below the median of 810 across 43 observational studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 60-85 years
  • Able to provide 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.

Exclusion criteria

Exclusion criteria:

  • ,
  • Use of inhalation and/or nasal the last month
  • Intubation or under invasive mechanical ventilation
  • Long-term antibiotic treatment prior to disease onset
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay

    Time frame: 1 month

Secondary outcomes

  1. Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry

    Time frame: 1 month

  2. Antibody titers in nasal cavity and blood by antigen-specific ELISA

    Time frame: 1 month

  3. Bacterial load and viral load in nasal cavity by specific qPCR assay

    Time frame: 1 month

  4. Levels of serum cytokines by multiplex assay

    Time frame: 1 month

  5. Clinical outcome measure 1: pneumonia diagnostic

    Probability of diagnosis of pneumonia (on a 3-Likert scale: low, intermediate and high level of probability)

    Time frame: 1 month

  6. Clinical outcome measure 2: CURB65 severity score

    Time frame: 1 month

  7. Clinical outcome measure 3: nature and severity of symptoms (CAP score)

    Time frame: 1 month

  8. Clinical outcome measure 4: number of days with fever

    Time frame: 1 month

  9. Clinical outcome measure 5: number of days with oxygen

    Time frame: 1 month

  10. Clinical outcome measure 6: highest FiO2

    Time frame: 1 month

  11. Clinical outcome measure 7: cardiac complication

    Time frame: 1 month

  12. Clinical outcome measure 8: secondary bacterial infection

    Only for group 2 patients (viral infection)

    Time frame: 1 month

  13. Clinical outcome measure 9: transfer to ICU or IMCU

    Time frame: 1 month

  14. Clinical outcome measure 10: length of stay in intensive care

    Time frame: 1 month

  15. Clinical outcome measure 11: intubation or mechanical ventilation

    Time frame: 1 month

  16. Clinical outcome measure 12: transfer to rehabilitation or institutionalization

    Time frame: 1 month

  17. Clinical outcome measure 13: mortality

    Time frame: 1 month

  18. Clinical outcome measure 14: rehospitalization

    Time frame: 1 month

  19. Clinical outcome measure 15: medical consultation for a respiratory disease

    Time frame: 1 month

  20. Clinical outcome measure 16: new prescription of antibiotics or corticosteroids

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2024 (actual). Primary completion is estimated for Nov 2026, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2025
First posted
May 31, 2025
StartActual
Dec 3, 2024
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06998251
Responsible party
Prof. Arnaud Didierlaurent (Professor, University of Geneva, Switzerland) — Principal investigator
First posted
May 31, 2025
Start date
Dec 3, 2024
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
May 31, 2025

Study contacts

Jennifer Villers, PhD
Contact
jennifer.villers@hug.ch
+41 79 553 88 86
Arnaud Didierlaurent, PhD
principal investigator · University of Geneva
Virginie Prendki, MD
principal investigator · University Hospital, Geneva

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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