About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay
Secondary outcomes
Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry
Antibody titers in nasal cavity and blood by antigen-specific ELISA
Bacterial load and viral load in nasal cavity by specific qPCR assay
Levels of serum cytokines by multiplex assay
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Geneva
Lead sponsor
University of Geneva, Switzerland
Sponsor institution