Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 6:46 PM
Study NCT ID:
NCT03237403
Status:
UNKNOWN
Last Update Posted:
2017-08-03
First Post:
2017-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hospital Orientation Since SAMU Regulation Centre Call
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2017-07-31', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Admission Service', 'timeFrame': '1 day', 'description': 'Emergency department or intensive care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Adults', 'Pre hospital settings', 'Triage', 'Hospital orientation', 'Outcome'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit', 'detailedDescription': 'Anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call for patients with suspected sepsis and their subsequent hospital orientation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects calling the SAMU regulation centre call with a clinical suspected sepsis history', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults (age\\>18years)\n* patients with suspected sepsis state at the regulation SAMU centre call\n\nExclusion Criteria: minor (age\\<18years)'}, 'identificationModule': {'nctId': 'NCT03237403', 'briefTitle': 'Hospital Orientation Since SAMU Regulation Centre Call', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Necker-Enfants Malades'}, 'officialTitle': 'Study of Association Between Clinical Criteria Collected at the SAMU Regulation Centre Call and the Hospital Orientation of Patients With Suspected Sepsis State', 'orgStudyIdInfo': {'id': '2017-A02335-48'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational study', 'type': 'OTHER', 'description': 'observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain Jouffroy, MD', 'role': 'CONTACT', 'email': 'romain.jouffroy@aphp.fr', 'phone': '+3314495989'}, {'name': 'Benoit Vivien, MD, PhD', 'role': 'CONTACT', 'email': 'benoit.vivien@aphp.fr', 'phone': '+33144492424'}], 'facility': 'APHP Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Romain Jouffroy, MD', 'role': 'CONTACT', 'email': 'romain.jouffroy@aphp.fr', 'phone': '+3314495989'}, {'name': 'Benoit Vivien, MD, PhD', 'role': 'CONTACT', 'email': 'benoit.vivien@aphp.fr', 'phone': '+33144492424'}], 'overallOfficials': [{'name': 'Romain Jouffroy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP Necker Enfants Malades SAMU 75'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD sharing plan is planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Necker-Enfants Malades', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Romain Jouffroy', 'investigatorAffiliation': 'Hôpital Necker-Enfants Malades'}}}}