Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT03920735
Status:
UNKNOWN
Last Update Posted:
2019-04-19
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short- and long-term survival, overall and in specific subgroups of patients', 'timeFrame': 'Long-term time point : 1st may 2019'}, {'measure': 'Short- and long-term survival, overall and in specific subgroups of patients', 'timeFrame': 'Short term : 1 month'}, {'measure': 'Short- and long-term survival, overall and in specific subgroups of patients', 'timeFrame': 'Short term : 3 months'}, {'measure': 'Short- and long-term survival, overall and in specific subgroups of patients', 'timeFrame': 'Short term : 6 months'}], 'secondaryOutcomes': [{'measure': 'Risk factors predisposing to opportunistic infections - age - gender - Type of work - Location - Tobacco use', 'timeFrame': 'first day of opportunistic infection'}, {'measure': 'Prognosis factors in patients with opportunistic infection affecting the response to antimicrobial therapy (using response criteria defined by EORTC/MSG)', 'timeFrame': 'first day of opportunistic infection'}, {'measure': 'Identification of baseline prognosis factors affecting the 3 months survival', 'timeFrame': 'first day of opportunistic infection'}, {'measure': 'Identification of baseline prognosis factors affecting the 6 months survival', 'timeFrame': 'first day of opportunistic infection'}, {'measure': 'Incidence of specific opportunistic infections in different host groups', 'timeFrame': 'evolution of a 20-year-period'}, {'measure': 'Description of imaging patterns opportunistic infections: analysis of chest CT-scan and cerebral CT-scan and MRI by radiologists', 'timeFrame': 'at first day of infection and up to 12 weeks'}, {'measure': 'Assessment of performance of Aspergillus galactomannan detection test in serum', 'timeFrame': 'at onset and up to 1 week'}, {'measure': 'Assessment of performance of Aspergillus galactomannan detection test in bronchoalveolar lavage', 'timeFrame': 'at onset and up to 1 week'}, {'measure': 'Response rate', 'timeFrame': 'at 1, 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Disease', 'Neoplams', 'Transplantation', 'Immunologic Deficiency Syndromes', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'The analysis of a cohort of consecutive non-selected patients from the Strasbourg University Hospital, and therefore representative of the real life, will allow better identifying the risk factors for these infections (by comparison with a cohort of patient with similar conditions of immunosuppression and no infection) and improving the diagnosis and therapeutic management.\n\nThe primary objective is to identify prognosis factors affecting survival in patients with opportunistic infections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in any department of the University Hospital of Strasbourg since 1997 Opportunistic infectious disease occurrence in immunocompromised or frail patients.\n\nIn case of epidemiological study, patients from a control group with the same characteristics but without infection can be included.', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Non selected consecutive immunocompromised or frail patients with an opportunistic infection\n* Hospitalized in any of the department of the University Hospital of Strasbourg\n* For epidemiological study, patients with similar immunodepression of frail condition and no opportunistic infection\n\nExclusion criteria:\n\n\\- Opposition of the patient to use his personal data'}, 'identificationModule': {'nctId': 'NCT03920735', 'briefTitle': 'Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients', 'orgStudyIdInfo': {'id': '1INFOPP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Opportunistic infection', 'description': 'Immunocompromised or frail patients with an opportunistic infection'}, {'label': 'Control group', 'description': 'Immunocompromised or frail patients with no opportunistic infection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Raoul HERBRECHT, MD', 'role': 'CONTACT', 'email': 'raoul.herbrecht@chru-strasbourg.fr', 'phone': '03 88 12 83 79', 'phoneExt': '0033'}, {'name': 'Raoul Raoul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital, Strasbourg, france', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Raoul HERBRECHT, MD', 'role': 'CONTACT', 'email': 'raoul.herbrecht@chru-strasbourg.fr', 'phone': '03 88 12 83 79', 'phoneExt': '0033'}], 'overallOfficials': [{'name': 'Raoul HERBRECHT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}