Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT07013006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009617', 'term': 'Nocardia Infections'}], 'ancestors': [{'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-05-30', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage reduction in cerebral nocardiosis lesions', 'timeFrame': '12 months', 'description': 'Percentage reduction in cerebral nocardiosis lesions in patients with a favorable evolution and those with an unfavorable evolution at 12 months from diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Percentage of CT brain scans suggestive of cerebral nocardiosis', 'timeFrame': '12 months', 'description': 'Percentage of CT brain scans finding abnormalities suggestive of cerebral nocardiosis, considering MRI as the gold standard for diagnosing cerebral nocardiosis.'}, {'measure': 'Description of the variation in radiological presentation of cerebral nocardiosis lesions', 'timeFrame': '12 months', 'description': "Description of the variation in radiological presentation (number of abscesses, abscesses size, contrast uptake, vasculitic lesions, associated ventriculitis) according to the patient's background (transplantation, anti-GM-CSF antibodies, allogeneic CSH graft, others)."}, {'measure': 'Percentage of cerebral vasculitis lesions', 'timeFrame': '12 months', 'description': 'Percentage of cerebral vasculitis lesions on brain MRI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nocardiosis', 'Nocardia spp.', 'Radiological monitoring', 'Cerebral involvement'], 'conditions': ['Nocardiosis']}, 'referencesModule': {'references': [{'pmid': '34596213', 'type': 'BACKGROUND', 'citation': 'Averbuch D, De Greef J, Dureault A, Wendel L, Tridello G, Lebeaux D, Mikulska M, Gil L, Knelange N, Zuckerman T, Roussel X, Robin C, Xhaard A, Aljurf M, Beguin Y, Le Bourgeois A, Botella-Garcia C, Khanna N, Van Praet J, Kroger N, Blijlevens N, Ducastelle Lepretre S, Ho A, Roos-Weil D, Yeshurun M, Lortholary O, Fontanet A, de la Camara R, Coussement J, Maertens J, Styczynski J; European Study Group for Nocardia in Hematopoietic Cell Transplantation. Nocardia Infections in Hematopoietic Cell Transplant Recipients: A Multicenter International Retrospective Study of the Infectious Diseases Working Party of the European Society for Blood and Marrow Transplantation. Clin Infect Dis. 2022 Aug 24;75(1):88-97. doi: 10.1093/cid/ciab866.'}, {'pmid': '28329348', 'type': 'BACKGROUND', 'citation': 'Lebeaux D, Freund R, van Delden C, Guillot H, Marbus SD, Matignon M, Van Wijngaerden E, Douvry B, De Greef J, Vuotto F, Tricot L, Fernandez-Ruiz M, Dantal J, Hirzel C, Jais JP, Rodriguez-Nava V, Jacobs F, Lortholary O, Coussement J; European Study Group for Nocardia in Solid Organ Transplantation; European Study Group for Nocardia in Solid Organ Transplantation. Outcome and Treatment of Nocardiosis After Solid Organ Transplantation: New Insights From a European Study. Clin Infect Dis. 2017 May 15;64(10):1396-1405. doi: 10.1093/cid/cix124.'}]}, 'descriptionModule': {'briefSummary': 'Nocardiosis is a rare infection caused by bacteria of the genus Nocardia spp. It primarily affects immunocompromised individuals, such as solid organ or hematopoietic stem cell transplant recipients, as well as individuals with anti-GM-CSF antibodies. The infection typically begins by inhalation, affecting the lungs, with frequent hematogenous spread to the brain and soft tissues. Cerebral involvement is present in 20 to 40% of cases, although 40% of patients remain neurologically asymptomatic.\n\nTreatment consists of prolonged antibiotic therapy and, sometimes, surgical drainage for large or refractory abscesses. Mortality associated with cerebral involvement varies between 20 and 40%. Although radiological improvements are observed under treatment, the link between image changes and clinical prognosis remains uncertain. Regular radiological monitoring is recommended during and after treatment, although the expected evolution has not been described in the literature.', 'detailedDescription': 'Nocardiosis is a rare infection caused by bacteria of the genus Nocardia spp. It primarily affects immunocompromised individuals, such as solid organ or hematopoietic stem cell transplant recipients, as well as individuals with anti-GM-CSF antibodies. The infection typically begins by inhalation, affecting the lungs, with frequent hematogenous spread to the brain and soft tissues. Cerebral involvement is present in 20 to 40% of cases, although 40% of patients remain neurologically asymptomatic. Brain imaging is essential for diagnosis, with MRI often being preferred due to its sensitivity. Images often show multiple abscesses, but without sufficient specificity to differentiate nocardiosis from other pathogens. New MRI techniques could improve lesion characterization.\n\nTreatment consists of prolonged antibiotic therapy and, sometimes, surgical drainage for large or refractory abscesses. Mortality associated with cerebral involvement varies between 20 and 40%. Although radiological improvements are observed under treatment, the link between image changes and clinical prognosis remains uncertain. Regular radiological monitoring is recommended during and after treatment, although the expected evolution has not been described in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with cerebral nocardiosis and cared at an Assistance Publique -Hôpitaux de Paris hospital between 01/01/2004 and 01/12/2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minor or adult patient with cerebral nocardiosis, defined by the presence of compatible clinical and radiological signs associated with the detection of Nocardia spp. in a biological sample (cerebral or extracerebral).\n* With available imaging tests:\n\n * All patients with 3 brain imaging tests at the 3 stages of treatment: within 2 weeks of diagnosis, upon transition to maintenance treatment (3-6 weeks after the start of treatment), and at the end of treatment (between 1 month before and 1 month after the end of antibiotic treatment). MRI scans are preferred; in the absence of MRI images, contrast-enhanced CT scans will be included.\n * OR: any patient who has undergone an MRI and a contrast-enhanced CT scan within two weeks of diagnosis, with the two tests performed within 72 hours of each other.\n * OR: any patient with a multimodal brain MRI at any time during infection, preferably within one month of diagnosis.\n\nExclusion Criteria:\n\n* Refusal or impossibility of information.'}, 'identificationModule': {'nctId': 'NCT07013006', 'acronym': 'CENOCIM', 'briefTitle': 'Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Retrospective Study to Assess the Evolution of MRI or CT Lesions in Treated CNS Nocardiosis', 'orgStudyIdInfo': {'id': 'APHP250649'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patient suffering from cerebral nocardiosis defined by the presence of compatible clinical and radiological signs associated with the detection of Nocardia spp. in a biological sample (cerebral or extra-cerebral) between 01/01/2004 and 01/12/2024 with data collection that may continue 12 months after the end of treatment.', 'interventionNames': ["Other: Collection of data from the patient's medical file"]}], 'interventions': [{'name': "Collection of data from the patient's medical file", 'type': 'OTHER', 'description': "Collection of data from the patient's medical file.", 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'contacts': [{'name': 'Frédéric MD Mechaï', 'role': 'CONTACT', 'email': 'frederic.mechai@aphp.fr', 'phone': '0148957100'}], 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'contacts': [{'name': 'Aurélien MD DINH', 'role': 'CONTACT', 'email': 'aurelien.dinh@aphp.fr', 'phone': '0149095645', 'phoneExt': '+33'}], 'facility': 'Hôpital Ambroise-Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'contacts': [{'name': 'Antoine MD Hamon', 'role': 'CONTACT', 'email': 'antoine.hamon@aphp.fr', 'phone': '0140875934', 'phoneExt': '+33'}], 'facility': 'Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'contacts': [{'name': 'Violaine MD Esnault', 'role': 'CONTACT', 'phone': '0145178109'}], 'facility': 'Hôpital Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'contacts': [{'name': 'Laura MD Lévi', 'role': 'CONTACT', 'email': 'laura.levi@aphp.fr', 'phone': '0145217421', 'phoneExt': '+33'}], 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'David MD, PhD Lebeaux', 'role': 'CONTACT', 'email': 'david.lebeaux@aphp.fr', 'phone': '0142494683', 'phoneExt': '+33'}], 'facility': 'Hôpital Saint-Louis- Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Fanny MD Alby-Laurent', 'role': 'CONTACT', 'email': 'fanny.alby-laurent@aphp.fr', 'phone': '0144736346'}], 'facility': 'Hôpital Armand-Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Ugo MD Françoise', 'role': 'CONTACT', 'email': 'ugo.francoise@aphp.fr', 'phone': '0149282445'}], 'facility': 'Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Alexandre MD Bleibtreu', 'role': 'CONTACT', 'email': 'alexandre.bleibtreu@aphp.fr', 'phone': '0142160159'}], 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Caroline MD, PhD Charlier', 'role': 'CONTACT', 'email': 'caroline.charlier@aphp.fr', 'phone': '0158414141'}], 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Emmanuel MD Lafont', 'role': 'CONTACT', 'email': 'emmanuel.lafont@aphp.fr', 'phone': '0156095700'}], 'facility': 'Hôpital Européen Georges-Pompidou, HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Margaux MD Garzaro', 'role': 'CONTACT', 'email': 'margaux.garzaro@aphp.fr', 'phone': '0144494017', 'phoneExt': '+33'}], 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Bénédicte MD, PhD Neven', 'role': 'CONTACT', 'email': 'benedicte.neven@nck.aphp.fr', 'phone': '0144494824', 'phoneExt': '+33'}], 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Yousra MD Kherabi', 'role': 'CONTACT', 'email': 'yousra.kherabi@aphp.fr', 'phone': '0140258892'}], 'facility': 'Hôpital Bichat - Claude-Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Margaux MD Garzaro', 'role': 'CONTACT', 'email': 'margaux.garzaro@aphp.fr', 'phone': '0144494017', 'phoneExt': '+33'}, {'name': 'Hélène Morel', 'role': 'CONTACT', 'email': 'helene.morel@aphp.fr', 'phone': '0171196346', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Margaux MD Garzaro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Olivier MD, PhD Lortholary', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}