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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-85
SponsorUniversity Hospital, Geneva

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

280 Participants
are grouped into 3 trial groups
Group A: Spn patients
Group B: Flu/RSV patients
Group C: Asymptomatic Spn carriers

Trial outcomes

Primary outcomes

1

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

Time frame
1 month

Secondary outcomes

1

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

Time frame
1 month
2

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

Time frame
1 month
3

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

Time frame
1 month
4

Levels of serum cytokines by multiplex assay

Time frame
1 month

Other outcomes

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