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

NCT06998251 | Recruiting

• 1 other identifier: 2024-01135
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infections; Respiratory Syncytial Virus (RSV) Infection; Influenza Infection

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (20)

• 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

• Bacterial load and viral load in nasal cavity by specific qPCR assay

  1 month

• Levels of serum cytokines by multiplex assay

  1 month

• Clinical outcome measure 1: pneumonia diagnostic

  1 month

Study Arms (3)

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

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nasal cells, nasal lining fluid, saliva

MeSH Terms

Conditions

Pneumococcal Infections; Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Arnaud Didierlaurent, PhD

  University of Geneva

  PRINCIPAL INVESTIGATOR

• Virginie Prendki, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Villers, PhD

CONTACT

+41 79 553 88 86; jennifer.villers@hug.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: May 31, 2025
• Study Start: December 3, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

CH (1)