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

University Hospital, Geneva280 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

280

Conditions

Pneumococcal Infections Respiratory Syncytial Virus (RSV) Infection Influenza Infection

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry

Time frame: 1 month

Antibody titers in nasal cavity and blood by antigen-specific ELISA

Time frame: 1 month

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

Time frame: 1 month

Levels of serum cytokines by multiplex assay

Time frame: 1 month

Clinical outcome measure 1: pneumonia diagnostic

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

Time frame: 1 month

Clinical outcome measure 2: CURB65 severity score

Time frame: 1 month

Clinical outcome measure 3: nature and severity of symptoms (CAP score)

Time frame: 1 month

Clinical outcome measure 4: number of days with fever

Time frame: 1 month

Clinical outcome measure 5: number of days with oxygen

Time frame: 1 month

Clinical outcome measure 6: highest FiO2

Time frame: 1 month

Clinical outcome measure 7: cardiac complication

Time frame: 1 month

Clinical outcome measure 8: secondary bacterial infection

Only for group 2 patients (viral infection)

Time frame: 1 month

Clinical outcome measure 9: transfer to ICU or IMCU

Time frame: 1 month

Clinical outcome measure 10: length of stay in intensive care

Time frame: 1 month

Clinical outcome measure 11: intubation or mechanical ventilation

Time frame: 1 month

Clinical outcome measure 12: transfer to rehabilitation or institutionalization

Time frame: 1 month

Clinical outcome measure 13: mortality

Time frame: 1 month

Clinical outcome measure 14: rehospitalization

Time frame: 1 month

Clinical outcome measure 15: medical consultation for a respiratory disease

Time frame: 1 month

Clinical outcome measure 16: new prescription of antibiotics or corticosteroids

Time frame: 1 month

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts