NCT06998251 In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)
| NCT ID | NCT06998251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | Pneumococcal Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 280 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 280 participants in total. It began in 2024-12-03 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Arnaud Didierlaurent, PhD
PRINCIPAL INVESTIGATOR
University of Geneva, Switzerland
Frequently Asked Questions
Who can join the NCT06998251 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Pneumococcal Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06998251 currently recruiting?
Yes, NCT06998251 is actively recruiting participants. Contact the research team at jennifer.villers@hug.ch for enrollment information.
Where is the NCT06998251 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT06998251 clinical trial?
NCT06998251 is sponsored by University Hospital, Geneva. The principal investigator is Arnaud Didierlaurent, PhD at University of Geneva, Switzerland. The trial plans to enroll 280 participants.