Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-02 @ 12:31 AM
Study NCT ID:
NCT04034550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2019-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort of Hospitalized Patients Suspected of Leptospirosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D000094902', 'term': 'Blood Banking'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001793', 'term': 'Blood Preservation'}, {'id': 'D014021', 'term': 'Tissue Preservation'}, {'id': 'D011309', 'term': 'Preservation, Biological'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009927', 'term': 'Tissue and Organ Procurement'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease severity', 'timeFrame': '0 to 21 days after onset of symptoms', 'description': 'Rate of death or severe organ insuffisiency'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leptospirosis', 'hospitalization'], 'conditions': ['Leptospirosis']}, 'descriptionModule': {'briefSummary': 'COLEPT is a prospective interventional study that intends to better inform about leptospirosis, a neglected zoonotic infectious disease. During prospective follow-up of hospitalized acute leptospirosis cases, the participants will be assessed during 1 year for epidemiological, clinical, bacteriological and immunological data. Main intervention consists in blood sampling and biological bank constitution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* clinico-biological manifestations compatible with acute leptospirosis OR proven leptospirosis with serological testing or PCR\n* onset of symptoms within 21 days\n* participant benefits of health insurance\n\nExclusion Criteria:\n\n* participant's refusal, or refusal from his relatives in case of major incapacity of the eligible participant precluding expression of his will (coma, stay in intensive care unit))"}, 'identificationModule': {'nctId': 'NCT04034550', 'acronym': 'COLEPT', 'briefTitle': 'Cohort of Hospitalized Patients Suspected of Leptospirosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Cohort of Hospitalized Patients Suspected of Leptospirosis', 'orgStudyIdInfo': {'id': 'C17-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hospitalized patients diagnosed with leptospirosis', 'description': 'hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection', 'interventionNames': ['Other: Blood and urine sampling and blood banking']}], 'interventions': [{'name': 'Blood and urine sampling and blood banking', 'type': 'OTHER', 'description': 'In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.', 'armGroupLabels': ['hospitalized patients diagnosed with leptospirosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97470', 'city': 'Saint-Benoît', 'state': 'Reunion', 'country': 'France', 'facility': 'Groupe Hospitalier Est Réunion (GHER)', 'geoPoint': {'lat': 46.55025, 'lon': 0.34177}}, {'zip': '97400', 'city': 'Saint-Denis', 'state': 'Reunion', 'country': 'France', 'facility': 'CHU de La Réunion site Nord', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '97460', 'city': 'Saint-Paul', 'state': 'Reunion', 'country': 'France', 'facility': 'Centre Hospitalier Ouest Réunion (CHOR)', 'geoPoint': {'lat': 49.42962, 'lon': 2.00755}}, {'zip': '97410', 'city': 'Saint-Pierre', 'state': 'Reunion', 'country': 'France', 'facility': 'CHU de La Réunion site Sud (GHSR)', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}], 'overallOfficials': [{'name': 'Loïc RAFFRAY, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Reunion, INSERM, CNRS, IRD UMR PIMIT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}