Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-25 @ 12:59 AM
Study NCT ID:
NCT03280992
Status:
TERMINATED
Last Update Posted:
2021-12-02
First Post:
2017-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Acquired Sepsis Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 796}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study not feasible in practise', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2017-08-18', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of morbidity in patients with septic syndrome of community origin', 'timeFrame': 'Day 90', 'description': 'Study of prognostic factors'}, {'measure': 'Internal validity, severity score', 'timeFrame': 'Day 90'}, {'measure': 'Internal validity, triage score by orientation nurses', 'timeFrame': 'Day 90'}, {'measure': 'Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality', 'timeFrame': 'Day 90'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Septic Syndrome', 'Septic Shock']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.', 'detailedDescription': 'Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with a community infectious diseases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18 years old\n* Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes\n\nExclusion Criteria:\n\n* Written objection from the patient to the computer processing of his data\n* Pregnant women\n* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty'}, 'identificationModule': {'nctId': 'NCT03280992', 'acronym': 'CASC', 'briefTitle': 'Community Acquired Sepsis Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Community Acquired Sepsis Cohort', 'orgStudyIdInfo': {'id': '35RC16_3024_CASC'}}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}