Influenza Infection, Pneumococcal Infections, Respiratory Syncytial Virus (RSV) Infection
Conditions
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.
Interventions
None listed
Sponsors
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | — |
| Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry | 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 11: intubation or mechanical ventilation | 1 month | — |
| Clinical outcome measure 12: transfer to rehabilitation or institutionalization | 1 month | — |
| Clinical outcome measure 13: mortality | 1 month | — |
| Clinical outcome measure 14: rehospitalization | 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 | — |
| Clinical outcome measure 7: cardiac complication | 1 month | — |
Countries
Switzerland
Contacts
Primary ContactJennifer Villers, PhD
Outcome results
None listed