In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pneumococcal Infections, Respiratory Syncytial Virus (RSV) Infection, Influenza Infection. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Primary outcome measures
- Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay [Time frame: 1 month]
Secondary outcome measures (12)
- 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 [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 [Time frame: 1 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Geneva University Hospitals — Geneva
Identifiers
NCT: NCT06998251 · 2024-01135