Clinical trial NCT06998251: In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)
Official title: In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumococcal Infections
Respiratory Syncytial Virus (RSV) Infection
Influenza Infection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 280
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay
timeFrame: 1 month
Secondary outcomes:
measure: Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry
timeFrame: 1 month
measure: Antibody titers in nasal cavity and blood by antigen-specific ELISA
timeFrame: 1 month
measure: Bacterial load and viral load in nasal cavity by specific qPCR assay
timeFrame: 1 month
measure: Levels of serum cytokines by multiplex assay
timeFrame: 1 month
measure: Clinical outcome measure 1: pneumonia diagnostic
timeFrame: 1 month
measure: Clinical outcome measure 2: CURB65 severity score
timeFrame: 1 month
measure: Clinical outcome measure 3: nature and severity of symptoms (CAP score)
timeFrame: 1 month
measure: Clinical outcome measure 4: number of days with fever
timeFrame: 1 month
measure: Clinical outcome measure 5: number of days with oxygen
timeFrame: 1 month
measure: Clinical outcome measure 6: highest FiO2
timeFrame: 1 month
measure: Clinical outcome measure 7: cardiac complication
timeFrame: 1 month
measure: Clinical outcome measure 8: secondary bacterial infection
timeFrame: 1 month
measure: Clinical outcome measure 9: transfer to ICU or IMCU
timeFrame: 1 month
measure: Clinical outcome measure 10: length of stay in intensive care
timeFrame: 1 month
measure: Clinical outcome measure 11: intubation or mechanical ventilation
timeFrame: 1 month
measure: Clinical outcome measure 12: transfer to rehabilitation or institutionalization
timeFrame: 1 month
measure: Clinical outcome measure 13: mortality
timeFrame: 1 month
measure: Clinical outcome measure 14: rehospitalization
timeFrame: 1 month
measure: Clinical outcome measure 15: medical consultation for a respiratory disease
timeFrame: 1 month
measure: Clinical outcome measure 16: new prescription of antibiotics or corticosteroids
timeFrame: 1 month
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University of Geneva
name: Arnaud Didierlaurent, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Virginie Prendki, MD
role: PRINCIPAL_INVESTIGATOR
References: