Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT06828458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-14
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determining Elements of Anti-Fungal Immunity in BURN Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood Rectal swab skin swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 327}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive fungal disease (IFD) onset during hospitalisation time', 'timeFrame': 'Up to 18 months', 'description': 'Proven IFD according to EORTC/MSGERC criteria applicable for invasive candidiasis. Putative invasive mold infection is defined with ≥ 2 positive culture from skin biopsy/bronchoalveolar lavage or ≥ 2 positive blood specific qPCR (aspergilosis, mucorales, fusariosis) or a combination of both. Possible invasive mold infection is defined with only one positive mycological criterion.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'At day 30'}, {'measure': 'Overall survival', 'timeFrame': 'At day 90'}, {'measure': 'Hospital mortality', 'timeFrame': 'Up to 18 months'}, {'measure': 'Incidence of organ failure during hospitalisation', 'timeFrame': 'Up to 18 months', 'description': '* Acute respiratory distress syndrome defined by the modified Berlin criteria, or\n* Acute kidney injury as defined by the KDIGO consensus, or\n* Septic shock and doses of catecholamines defined by SEPSIS-3'}, {'measure': 'Severity score at admission', 'timeFrame': 'At inclusion', 'description': 'SAPS 2 : Simplified Acute Physiology Score II The score can range from 0 to 163. Higher score indicates more severe illness and a higher risk of mortality. Lower score indicates less severe illness and a lower risk of mortality.'}, {'measure': 'Severity score at admission', 'timeFrame': 'At inclusion', 'description': 'ABSI Acute Bowel Ischemia Severity Index The score ranges from 0 to 10. A higher score indicates a more severe case and a higher risk of mortality.'}, {'measure': 'Severity score at admission', 'timeFrame': 'At inclusion', 'description': 'SOFA score : Sequential Organ Failure Assessment The score can range from 0 to 24, with higher scores indicating more severe organ failure and a worse prognosis.'}, {'measure': 'Number of days without renal replacement therapy', 'timeFrame': 'At day 30'}, {'measure': 'Number of days without mechanical ventilation', 'timeFrame': 'At day 30'}, {'measure': 'Length of stay in Intensive Care Unit', 'timeFrame': 'Up to 18 months'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'Up to 18 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burn']}, 'descriptionModule': {'briefSummary': 'Scientific justification Invasive fungal diseases (IFDs) pose a substantial threat, especially in immunocompromised patients, necessitating urgent research focus and therapeutic advancements. The IFI-BURN study, involving a cohort of patients with severe burn injury (n=276), revealed a significant IFD incidence of 31.6% and underscored their critical impact on morbidity and mortality. While fungi are present everywhere, for moulds within the environment and for yeasts within our microbiota, why certain patients develop IFDs and others do not, remains poorly understood. The answer most likely resides in the impact of the burn injury on the immune response, loss of skin barrier and particular predisposing immune phenotype of patients. The immune system is composed of both cellular and humoral components, but the latter is far less studied in antifungal immunity although they exert multiple antimicrobial mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with burn injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBurn patients\n\n* Adult patients ≥ 18 years old\n* Admission \\< 4 days following burn injury\n* Total burn surface Area ≥ 15%\n* Non opposition of the patient or his/her relatives to the research\n* Affiliation to social security or any health insurance\n\nExclusion Criteria:\n\n* Pregnancy\n* Opposition of the patient or his/her relatives\n* Decision not to resuscitate or to limit or stop active therapies'}, 'identificationModule': {'nctId': 'NCT06828458', 'acronym': 'DEFI-BURN', 'briefTitle': 'Determining Elements of Anti-Fungal Immunity in BURN Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Determining Elements of Anti-Fungal Immunity in BURN Patients', 'orgStudyIdInfo': {'id': 'APHP241672'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients with burn injury', 'interventionNames': ['Other: Biological sampling']}], 'interventions': [{'name': 'Biological sampling', 'type': 'OTHER', 'description': 'Whole blood on EDTA sample 2 tubes (5mL) PAXgene sample 1 tube (2.5 mL) Rectal swab Skin swab (1 swab for 5 anatomically burned sites)\n\nAt day 0, day 3, day 7, day 14, day 21', 'armGroupLabels': ['Adult patients with burn injury']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emmanuel Dudoignon, MD', 'role': 'CONTACT', 'email': 'emmanuel.dudoignon@aphp.fr', 'phone': '1 42 49 93 94', 'phoneExt': '+33'}, {'name': 'Jérôme Lambert, MD PhD', 'role': 'CONTACT', 'email': 'jerome.lambert@u-paris.fr', 'phone': '+33142499742', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}