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

University Hospitals (UH)

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06998251

2024-01135

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

280 participants in 3 patient groups

Spn patients

Description:

Patients hospitalized with community-acquired pneumonia due to a Streptococcus pneumoniae infection

Flu/RSV patients

Description:

Patients hospitalized with flu-like symptoms and a laboratory-confirmed influenza or RSV infection

Asymptomatic Spn carriers

Description:

Healthy people screened for asymptomatic carriage of Streptococcus pneumoniae