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

Recruiting

• Conditions: Pneumococcal Infections; Respiratory Syncytial Virus (RSV) Infection; Influenza Infection

• Registration Number: NCT06998251
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-03
• Study First Submitted: 2025-03-28
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay	1 month

Secondary Outcome Measures

Name	Time	Method
Bacterial load and viral load in nasal cavity by specific qPCR assay	1 month
Clinical outcome measure 7: cardiac complication	1 month
Clinical outcome measure 11: intubation or mechanical ventilation	1 month
Clinical outcome measure 12: transfer to rehabilitation or institutionalization	1 month
Clinical outcome measure 15: medical consultation for a respiratory disease	1 month
Clinical outcome measure 16: new prescription of antibiotics or corticosteroids	1 month
Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry	1 month
Antibody titers in nasal cavity and blood by antigen-specific ELISA	1 month
Levels of serum cytokines by multiplex assay	1 month
Clinical outcome measure 1: pneumonia diagnostic	1 month	Probability of diagnosis of pneumonia (on a 3-Likert scale: low, intermediate and high level of probability)
Clinical outcome measure 2: CURB65 severity score	1 month
Clinical outcome measure 3: nature and severity of symptoms (CAP score)	1 month
Clinical outcome measure 4: number of days with fever	1 month
Clinical outcome measure 5: number of days with oxygen	1 month
Clinical outcome measure 6: highest FiO2	1 month
Clinical outcome measure 8: secondary bacterial infection	1 month	Only for group 2 patients (viral infection)
Clinical outcome measure 9: transfer to ICU or IMCU	1 month
Clinical outcome measure 10: length of stay in intensive care	1 month
Clinical outcome measure 13: mortality	1 month
Clinical outcome measure 14: rehospitalization	1 month

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland