Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05413720
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2022-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007922', 'term': 'Leptospirosis'}], 'ancestors': [{'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes', 'timeFrame': 'at inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leptospirosis']}, 'descriptionModule': {'briefSummary': 'The research hypothesis is based on a suspected strong involvement of the immune system in the genesis of serious manifestations of the disease (hepatitis, renal failure, thrombocytopenia, intra-alveolar hemorrhage). The question asked is that of the state of the immune system (quantitative and qualitative: activation markers, production of cytokines) evaluated by the study of circulating innate immune cells (monocytes, neutrophils, dendritic cells, lymphocytes, platelets).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 4 years;\n* Weight ≥ 11 kg;\n* with ongoing symptoms compatible with a clinical diagnosis of leptospirosis.\n* AND having a diagnosis of leptospirosis confirmed according to standard care procedures: preferably by Polymerase Chain Reaction (PCR) (blood or urine) or, failing that, serology indicating a recent infection (positive Immunoglobulin M (IgM) or Microscopic Agglutination Test (MAT) technique with titer \\>1/400 for a pathogenic serogroup)\n* AND affiliated to a Social Security scheme\n\nExclusion Criteria:\n\n* Refusal of participation by the patient or his entourage if the patient is physically unable to give his opinion (coma, resuscitation, etc.).\n* Not affiliated with social security\n* Immunosuppression that may interfere with the interpretation of the results: chemotherapy in progress, immunosuppressants in progress for organ transplantation or autoimmune disease\n* Patient under legal protection (Guardianship, Curators)'}, 'identificationModule': {'nctId': 'NCT05413720', 'acronym': 'IMMUNOLEPTO', 'briefTitle': 'Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO', 'orgStudyIdInfo': {'id': '2017/CHU/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient with leptospirosis', 'interventionNames': ['Other: two additional blood samples specific to research']}], 'interventions': [{'name': 'two additional blood samples specific to research', 'type': 'OTHER', 'description': 'proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes in the acute phase', 'armGroupLabels': ['Patient with leptospirosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97470', 'city': 'Saint-Benoît', 'country': 'Reunion', 'facility': 'GHER', 'geoPoint': {'lat': -21.03795, 'lon': 55.71546}}, {'zip': '97400', 'city': 'Saint-Denis', 'country': 'Reunion', 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': -20.88231, 'lon': 55.4504}}, {'zip': '97460', 'city': 'Saint-Paul', 'country': 'Reunion', 'facility': 'CHOR', 'geoPoint': {'lat': -21.00961, 'lon': 55.27134}}, {'zip': '97448', 'city': 'Saint-Pierre', 'country': 'Reunion', 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}