Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-03-02 @ 4:05 PM
Study NCT ID:
NCT06774235
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060085', 'term': 'Coinfection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007371', 'term': 'Interferon-gamma'}], 'ancestors': [{'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016215', 'term': 'Macrophage-Activating Factors'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 326}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-10-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of secondary infection episodes', 'timeFrame': 'Day 90', 'description': 'Number of episodes divided by the follow-up length, in days, validated by an independent adjudication committee based on the current definitions.'}], 'secondaryOutcomes': [{'measure': 'Cause of mortality of participant', 'timeFrame': 'Day 90', 'description': 'All-cause ICU mortality and at Day 90'}, {'measure': 'Length of stay in the ICU and in the hospital', 'timeFrame': 'Day 90', 'description': 'Number of days spent in the ICU and in the hospital at Day 90'}, {'measure': 'Antibiotic consumption', 'timeFrame': 'Day 90', 'description': 'Name of antibiotics taken at Day 90'}, {'measure': 'Biological immune restoration', 'timeFrame': 'Day 10', 'description': 'Percentage of biological immune restoration (defined as an HLA-DR \\> 13 500 Ab/c \\[Antibodies bound per cell\\] and an absolute lymphocyte count \\> 1200 mm3) at Day 10'}, {'measure': 'Healthcare costs', 'timeFrame': 'Day 90', 'description': 'Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance'}, {'measure': 'Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR)', 'timeFrame': 'Day 90', 'description': 'Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90 according to sponsor causality assessment'}, {'measure': 'Antifungal consumption', 'timeFrame': 'Day 90', 'description': 'Name of antifungals taken at Day 90'}, {'measure': 'Antifungal consumption', 'timeFrame': 'Day 90', 'description': 'Dosage of antifungals taken at Day 90'}, {'measure': 'Antifungal consumption', 'timeFrame': 'Day 90', 'description': 'Duration of antifungals taken at Day 90'}, {'measure': 'Antibiotic consumption', 'timeFrame': 'Day 90', 'description': 'Dosage of antibiotics taken at Day 90'}, {'measure': 'Antibiotic consumption', 'timeFrame': 'Day 90', 'description': 'Duration of antibiotics taken at Day 90'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICU', 'Immuno-restauration', 'Secondary infections', 'Prevention'], 'conditions': ['Sustained Immunosuppression']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are:\n\nDoes Interferon-gamma:\n\n* reduces the Incidence of secondary infection episodes at three months\n* reduces the ICU mortality and at Day 90\n* reduces the ICU and hospital length of stay\n* induces Biological immune restoration at Day 10\n* has cost-consequence and cost-effectiveness\n\nResearchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression .\n\nParticipants will:\n\n* Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9\n* be monitored evety day until their ICU discharge and at day 30, 60 and 90'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient hospitalized in the ICU for at least 1 week\n* Expected length of stay in the ICU greater than 10 days at screening\n* At least 1 episode of multiple organ failure, defined as a SOFA ≥ 6 (excluding the respiratory component when related to a neurological failure), during the first 1 week of ICU hospitalization\n* Immunosuppression defined as an mHLA-DR \\< 8000 Ab/c and a lymphopenia \\< 1000/mm3 within a 96 hours time window\n* Patient or the legal representative giving consent must be able to understand the trial in its entirety\n* Patient affiliated to the social security system\n* For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90\n* For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90.\n\nExclusion Criteria:\n\n* Uncontrolled secondary infections ongoing at the time of screening\n* Participation in another research clinical trial within 30 days\n* Chemotherapy / radiation therapy within the last 6 weeks\n* Apache II ≥ 30 at screening\n* History of autoimmune disease\n* Organ or bone marrow transplant\n* History of hematologic malignancy\n* History of hepatitis C\n* HIV stage C within the last 12 months\n* Patients under legal protection\n* History of or ongoing tuberculosis\n* Chronic hepatitis B\n* Patients receiving immunosuppressive medications including patient receiving a steroid dose greater than 1mg/kg/day of prednisone equivalent for more than 1 week and patient that have been on corticosteroid for more than 3 months\n* Patient with thrombocytopenia below 50,000/mm3\n* Patient with traumatic brain and spinal injury\n* Pregnancy or breast feeding\n* Subjects with a history hypersensitivity to interferon gamma or excipient (Mannitol, Sodium succinate dibasic hexahydrate, Succinic acid, polysorbate 20), known latex hypersensitivity or other interferon\n* Hepatic cytolysis with AST/ALT \\> 5 times ULN (local laboratory)\n* Suspected acute pancreatitis with lipase or amylase \\> 3 times ULN (local laboratory)\n* Severe chronic renal failure (eGFR\\<10 ml/min/1.73m2 CKP-EPI method)\n* Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)\n* Mental state rendering the person giving consent incapable of understanding the trial\n* Patient deprived of liberty by judicial or administrative decision\n* Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinators'}, 'identificationModule': {'nctId': 'NCT06774235', 'acronym': 'PLATINIUM', 'briefTitle': 'Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial', 'orgStudyIdInfo': {'id': '87RI24_0040 (PLATINIUM)'}, 'secondaryIdInfos': [{'id': '2024-516780-93-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interferon-gamma', 'description': 'Injections of Interferon gamma-1b are sub-cutaneous and preferably in the deltoid region left or right or on the anterior part of the thigh.\n\n5 injections between day 1 and day 9', 'interventionNames': ['Drug: Interferon Gamma 1-b']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The comparative treatment will be a placebo, consisting in 0.5 ml of 0.9% sodium chloride solution only (same volume for interferon gamma-1b)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Interferon Gamma 1-b', 'type': 'DRUG', 'description': 'injection of interferon gamma 1-b', 'armGroupLabels': ['Interferon-gamma']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Injection of placebo in the same condition of experimental traitment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre ASFAR, MD', 'role': 'CONTACT', 'email': 'pierre.asfar@univ-angers.fr', 'phone': '+33241353815'}, {'name': 'Pierre ASFAR, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Angers university hospial', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '95107', 'city': 'Argenteuil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gaetan PLANTEFEVE, MD', 'role': 'CONTACT', 'email': 'gaetan.plantefeve@ch-argenteuil.fr', 'phone': '+33134231445'}, {'name': 'gaetan PLANTEFEVE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Argenteuil hospital', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '90015', 'city': 'Belfort', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julio BADIE, MD', 'role': 'CONTACT', 'email': 'Julio.BADIE@hnfc.fr', 'phone': '+33384981970'}, {'name': 'julio BADIE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Franche-comté north Hospital', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '19100', 'city': 'Brive-la-Gaillarde', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas PICHON, MD', 'role': 'CONTACT', 'email': 'nicolas.pichon@ch-brive.fr', 'phone': '+33555926013'}, {'name': 'Nicolas PICHON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brive Hospital', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas MALDINEY, MD', 'role': 'CONTACT', 'email': 'thomas.maldiney@ch-chalon71.fr', 'phone': '+33385910111'}, {'name': 'Thomas MALDINEY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chalon sur saone Hospital', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '21000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre QUENOT, MD', 'role': 'CONTACT', 'email': 'jean-pierre.quenot@chu-dijon.fr', 'phone': '+33380293685'}, {'name': 'Jean-Pierre QUENOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dijon University Hospital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Djillali ANNANE, MD', 'role': 'CONTACT', 'email': 'djillali.annane@rpc.aphp.fr', 'phone': '+33147107787'}, {'name': 'Djillali ANNANE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '78157', 'city': 'Le Chesnay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane LEGRIEL, MD', 'role': 'CONTACT', 'email': 'slegriel@ch-versailles.fr', 'phone': '+33139639717'}, {'name': 'Stéphane LEGRIEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Versailles Hospital', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '72000', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe GUITTON', 'role': 'CONTACT', 'email': 'cguitton@ch-lemans.fr', 'phone': 'MD'}, {'name': 'Christophe GUITTON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Le mans Hospital', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '62300', 'city': 'Lens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas VAN GRUNDEBEECK, MD', 'role': 'CONTACT', 'email': 'nvangrunderbeeck@ch-lens.fr', 'phone': '0321691088', 'phoneExt': '+33'}, {'name': 'Nicolas VAN GRUNDERBEECK, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Lens', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno FRANCOIS, MD', 'role': 'CONTACT', 'email': 'bruno.francois@chu-limoges.fr', 'phone': '0555058841', 'phoneExt': '+33'}, {'name': 'Bruno Francois, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Limoges University Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69002', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Claire LUKASZEWICZ, MD', 'role': 'CONTACT', 'email': 'anne-claire.lukaszewicz@chu-lyon.fr', 'phone': '+33472111327'}, {'name': 'Anne-Claire LUKASZEWICH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lyon Civils Hospices', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13915', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sami HRAIECH, MD', 'role': 'CONTACT', 'email': 'sami.hraiech@ap-hm.fr', 'phone': '+33491965836'}, {'name': 'Sami HRAIECH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '77000', 'city': 'Melun', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mehran MONCHI, MD', 'role': 'CONTACT', 'email': 'mehran.monchi@ghsif.fr', 'phone': '+33181742258'}, {'name': 'Mehran MONCHI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Melun Hospital', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'zip': '54035', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sébastien GIBOT, MD', 'role': 'CONTACT', 'email': 's.gibot@chru-nancy.fr', 'phone': '+33383852123'}, {'name': 'Sébastien GIBOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nancy University Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine ROQUILLY, MD', 'role': 'CONTACT', 'email': 'antoine.roquilly@chu-nantes.fr', 'phone': '+33240582230'}, {'name': 'Antoine ROQUILLY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45100', 'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François BARBIER, MD', 'role': 'CONTACT', 'email': 'francois.barbier@chr-orleans.fr', 'phone': '+33238514446'}, {'name': 'François BARBIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orléans Hospital', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas DEYE, MD', 'role': 'CONTACT', 'email': 'nicolas.deye@lrb.aphp.fr', 'phone': '+33149956347'}, {'name': 'nicolas DEYE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Laroiboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Luc DIEHL, MD', 'role': 'CONTACT', 'email': 'jean-luc.diehl@aphp.fr', 'phone': '+33156093204'}, {'name': 'Jean-Lus DIEHL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aphp - Hegp', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Paul MIRA, MD', 'role': 'CONTACT', 'email': 'jean-paul.mira@aphp.fr', 'phone': '+33158412501'}, {'name': 'Jean-Paul MIRA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Marc TADIE, MD', 'role': 'CONTACT', 'email': 'jeanmarc.tadie@chu-rennes.fr', 'phone': '+33299284248'}, {'name': 'Jean-Marc TADIE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Louise-Marie JANDEAUX, MD', 'role': 'CONTACT', 'email': 'Louise-marie.jandeaux@chru-strasbourg.fr', 'phone': '+33369551212'}, {'name': 'Louise-Marie JANDEAUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Strasbourg University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37000', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine GUILLON, MD', 'role': 'CONTACT', 'email': 'antoine.guillon@univ-tours.fr', 'phone': '+33139639717'}, {'name': 'Antoine GUILLON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tours University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}