Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:00 AM
Study NCT ID:
NCT07345169
Status:
RECRUITING
Last Update Posted:
2026-01-15
First Post:
2025-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival of patients admitted to intensive care.', 'timeFrame': '12 months', 'description': 'Difference in overall survival between ISU patients with different immunological and inflammatory profiles upon completion of the 12-month follow-up period.'}, {'measure': 'Multidimensional flow cytometry leukocyte profiling', 'timeFrame': 'Change from baseline to 12 months', 'description': 'The isolated cell samples will be analyzed to determine the absolute number and percentage of B cells, monocytes, CD4+ and CD8+ T cells, CD3+CD56+ NKT cells, and NK cells'}, {'measure': 'Inflammatory profile of ICU patients', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Inflammation-related protein biomarkers will be analyzed using Olink assay'}], 'secondaryOutcomes': [{'measure': 'Change in SOFA Score', 'timeFrame': 'Change from baseline to day 7', 'description': 'Sequential Organ Failure Assessment (SOFA) Score included the degree of dysfunction of six organ systems (Respiratory, Cardiovascular, Liver, Renal, Coagulation, Neurologic). Minimum score = 0 maximum score = 24. Higher scores indicate greater degree of dysfunction.'}, {'measure': 'Transcriptomic (scRNAseq) profiling of isolated leukocytes', 'timeFrame': 'Change from baseline to12 months', 'description': 'Change in the transcriptome of leukocytes isolated from blood, bronchoalveolar lavage fluid (BAL), cerebrospinal fluid (CSF), urine, and tissues, as measured by single cell RNA-sequencing using Flex technology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Critical illness', 'Intensive care', 'Immunology', 'Inflammation', 'Transcriptomics', 'scRNAseq', 'Flow cytometry', 'Nosocomial infections', 'Prognosis'], 'conditions': ['Critical Illness', 'Intensive Care Patients', 'Critical Illness Requiring Intensive Care - Sepsis', 'Critical Illness Requiring Intensive Care - Acute Brain Injury', 'Critical Illness Requiring Intensive Care - Major Surgery', 'Critical Illness Requiring Intensive Care - Polytrauma']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational physiopathological study aimed at evaluating the immunological and inflammatory determinants associated with the prognosis of patients admitted to intensive care units (ICU). The study will establish multidimensional models predicting one-year survival and the occurrence of nosocomial infections.\n\nPatients admitted to ICU undergo routine biological sampling. In addition to these, minimal supplementary samples will be collected for immunological and inflammatory biomarker analysis at admission, day 1, day 4, day 8, ICU discharge or day 28, and at 12 months. Additional samples may be taken during clinically significant events (nosocomial infections, complications).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (≥ 18 years old) admitted to intensive care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission to ICU within 24 hours\n\nExclusion Criteria:\n\n* Moribund patient (ECOG=4)\n* Legal protection (guardianship/curatorship)\n* Uninsured patients\n* Pre-existing immunosuppression (active/recent cancer, hematologic disease, autoimmune disease, organ transplant, HIV)\n* Pregnant or breastfeeding women\n* Participation in another interventional trial\n* Patients under AME'}, 'identificationModule': {'nctId': 'NCT07345169', 'acronym': 'IMMUNOREA', 'briefTitle': 'IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Studies on the Immunological and Inflammatory Determinants Associated With the Prognosis of Patients Admitted to Intensive Care', 'orgStudyIdInfo': {'id': 'APHP250001'}, 'secondaryIdInfos': [{'id': '2025-A00002-47', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles de Roquetaillade, MD', 'role': 'CONTACT', 'email': 'charles.de-roquetaillade@aphp.fr', 'phone': '+33 (0)149958515'}], 'facility': 'AP-HP Laribosière Hospital, Anesthesia and Critical Care Departement', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Charles de de Roquetaillade, MD', 'role': 'CONTACT', 'email': 'charles.de-roquetaillade@aphp.fr', 'phone': '+33 1 49 95 85 15'}, {'name': 'Benjamin Glenn Chousterman, MD PhD', 'role': 'CONTACT', 'email': 'benjamin.chousterman@aphp.fr', 'phone': '+33 1 49 95 85 15'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be made available upon reasonable request, after publication of primary results, for research purposes only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'INSERM U942', 'class': 'UNKNOWN'}, {'name': "Société Française d'Anesthésie et de Réanimation", 'class': 'OTHER'}, {'name': 'French Society for Intensive Care', 'class': 'OTHER'}, {'name': 'European Society of Intensive Care Medicine', 'class': 'OTHER'}, {'name': 'ZOLL Foundation, Fondation Les Gueules Cassées', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}