Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-30 @ 9:59 AM
Study NCT ID:
NCT04320394
Status:
WITHDRAWN
Last Update Posted:
2023-07-27
First Post:
2020-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Monocentric, Open-Label prospective study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'identification of patients with sepsis-induced immunosuppression in a population of patients with septic shock, by an objective and functional immunological test measuring the production of IFN-γ, the QuantiFERON Monitor®', 'timeFrame': '24 months', 'description': 'Use of an objective and functional immunological test measuring the production of IFN-γ, the QuantiFERON Monitor®'}], 'secondaryOutcomes': [{'measure': 'obtaining a threshold value of IFN - γ in the plasma of patients to define an immunosuppression threshold and then to predict the occurrence of secondary infectious complications.', 'timeFrame': '24 months', 'description': 'the value of IFN - γ (UI/mL) in the plasma will be mesured after stimulation of the immune cells,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'QuantiFERON Monitor® is an immunological test evaluating the nonspecific cellular response by measuring interferon gamma (IFNγ) secretions after T-cell and natural killer lymphocyte stimulation.\n\nThis study aims at evaluating sepsis-induced immunosuppression base on QuantiFERON Monitor® in patients presenting to the intensive care unit for septic shock. The sponsor expects to identify sepsis-induced immunodeficiency in patients through a better understanding of cellular and adaptive immune responses.', 'detailedDescription': 'A sepsis-induced immunosuppression phase has recently been characterized and has been associated with worse outcomes as well as increased healthcare costs. Furthermore, a marked suppression of the immune response has been partially described in patients hospitalized in the intensive care setting but its monitoring is not available in daily practice. QuantiFERON Monitor® is an immunological test evaluating the nonspecific cellular response by measuring interferon gamma (IFNγ) secretions after T-cell and natural killer lymphocyte stimulation. Several studies have shown the pertinence of this test, especially in patients with kidney failure requiring renal replacement therapy. Patients with lower IFNγ levels were also found to be at higher risk of infection.\n\nThis study aims at evaluating sepsis-induced immunosuppression base on QuantiFERON Monitor® in patients presenting to the intensive care unit for septic shock. The sponsor expects to identify sepsis-induced immunodeficiency in patients through a better understanding of cellular and adaptive immune responses. This should ultimately lead to determining thresholds for sepsis-related complications and identifying patients most at risk of sepsis-induced immuno-depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient hospitalized in intensive care and intensive care at Nice University Hospital and presenting with septic shock (defined by the presence of sepsis, the need for a vasopressor to maintain a MAP\\> 65mmHg and hyperlactatemia\\> 2mmol / l)\n* Free and express informed consent signed by the patient or the confidential counselor in case of impossibility (deferred consent of the patient as soon as his condition allows it)\n* Age\\> 18 years old\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Pregnant woman Patient under the age of 18\n* Patient under guardianship or curatorship or placed in detention\n* Patient with congenital or previously acquired immune deficiency\n* Patient on prior immunosuppressive treatment'}, 'identificationModule': {'nctId': 'NCT04320394', 'acronym': 'MONITOR SEPSIS', 'briefTitle': 'Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Patients Presenting to the Intensive Care Unit for Septic Shock', 'orgStudyIdInfo': {'id': '19-AOI-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Septic shock patients', 'description': 'Patients with septic shock will be taken from an additional tube to analyze their immune response', 'interventionNames': ['Diagnostic Test: QuantiFERON Monitor®']}], 'interventions': [{'name': 'QuantiFERON Monitor®', 'type': 'DIAGNOSTIC_TEST', 'description': 'The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock', 'armGroupLabels': ['Septic shock patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no data sharing plan is planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}