Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT06998251
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, nasal cells, nasal lining fluid, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry', 'timeFrame': '1 month'}, {'measure': 'Antibody titers in nasal cavity and blood by antigen-specific ELISA', 'timeFrame': '1 month'}, {'measure': 'Bacterial load and viral load in nasal cavity by specific qPCR assay', 'timeFrame': '1 month'}, {'measure': 'Levels of serum cytokines by multiplex assay', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 1: pneumonia diagnostic', 'timeFrame': '1 month', 'description': 'Probability of diagnosis of pneumonia (on a 3-Likert scale: low, intermediate and high level of probability)'}, {'measure': 'Clinical outcome measure 2: CURB65 severity score', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 3: nature and severity of symptoms (CAP score)', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 4: number of days with fever', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 5: number of days with oxygen', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 6: highest FiO2', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 7: cardiac complication', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 8: secondary bacterial infection', 'timeFrame': '1 month', 'description': 'Only for group 2 patients (viral infection)'}, {'measure': 'Clinical outcome measure 9: transfer to ICU or IMCU', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 10: length of stay in intensive care', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 11: intubation or mechanical ventilation', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 12: transfer to rehabilitation or institutionalization', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 13: mortality', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 14: rehospitalization', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 15: medical consultation for a respiratory disease', 'timeFrame': '1 month'}, {'measure': 'Clinical outcome measure 16: new prescription of antibiotics or corticosteroids', 'timeFrame': '1 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infections', 'Respiratory Syncytial Virus (RSV) Infection', 'Influenza Infection']}, 'descriptionModule': {'briefSummary': '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)).\n\nThe 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Aged 60-85 years\n* Able to provide informed consent either independently or by a legal representative\n* Group 1 (Spn pneumonia patients): clinical and/or radiological signs of pneumonia\n* Group 1 (Spn pneumonia patients): positive Spn urinary antigen and/or blood culture and/or positive sputum test.\n* Group 2 (viral respiratory infection patients): clinical signs of a respiratory infection\n* Group 2 (viral respiratory infection patients): positive test for influenza or RSV\n* Group 3 (asymptomatic Spn-carriers): healthy without clinical signs of infection and no lower respiratory symptoms within the last month.\n\nExclusion criteria:\n\n* Immunosuppression,\n* Use of inhalation and/or nasal steroids the last month\n* Intubation or under invasive mechanical ventilation\n* Long-term antibiotic treatment prior to disease onset'}, 'identificationModule': {'nctId': 'NCT06998251', 'acronym': 'NoseSpnElderly', 'briefTitle': 'In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)', 'orgStudyIdInfo': {'id': '2024-01135'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spn patients', 'description': 'Patients hospitalized with community-acquired pneumonia due to a Streptococcus pneumoniae infection'}, {'label': 'Flu/RSV patients', 'description': 'Patients hospitalized with flu-like symptoms and a laboratory-confirmed influenza or RSV infection'}, {'label': 'Asymptomatic Spn carriers', 'description': 'Healthy people screened for asymptomatic carriage of Streptococcus pneumoniae'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Jennifer Villers, PhD', 'role': 'CONTACT', 'email': 'jennifer.villers@hug.ch', 'phone': '+41795538886'}, {'name': 'Virginie Prendki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Jennifer Villers, PhD', 'role': 'CONTACT', 'email': 'jennifer.villers@hug.ch', 'phone': '+41 79 553 88 86'}], 'overallOfficials': [{'name': 'Arnaud Didierlaurent, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}, {'name': 'Virginie Prendki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Arnaud Didierlaurent', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}