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NCT Number: NCT06998251

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Jennifer Villers, PhD

CONTACT

[email protected]

+41795538886

Virginie Prendki, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

    Time frame: 1 month

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

  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

    Time frame: 1 month

    Only for group 2 patients (viral infection)

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Villers, PhD

CONTACT

[email protected]

+41 79 553 88 86

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Acronym: NoseSpnElderly

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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