Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
Study NCT ID:
NCT05249894
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of Sepsis Scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D064146', 'term': 'Chemotherapy-Induced Febrile Neutropenia'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D064147', 'term': 'Febrile Neutropenia'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality risk', 'timeFrame': 'At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline', 'description': 'Ability of NEWS and qSOFA score to predict mortality risk calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)'}], 'secondaryOutcomes': [{'measure': 'Systemic Inflammatory Response Syndrome (SIRS) development', 'timeFrame': 'At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline', 'description': 'Ability of NEWS and qSOFA score to predict SIRS development calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)'}, {'measure': 'Amine requirement', 'timeFrame': 'At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline', 'description': 'Ability of NEWS and qSOFA score to predict vasoactive drugs requirement calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)'}, {'measure': 'Respiratory failure', 'timeFrame': 'At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline', 'description': 'Ability of NEWS and qSOFA score to predict respiratory failure calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)'}, {'measure': 'Ventilation support', 'timeFrame': 'At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline', 'description': 'Ability of NEWS and qSOFA score to predict ventilation support necessity calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)'}, {'measure': 'Intensive care unit (ICU) admission', 'timeFrame': 'At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline', 'description': 'Ability of NEWS and qSOFA score to predict ICU admission calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)'}, {'measure': 'Bloodstream infections', 'timeFrame': 'From date of fever onset until the date of fever resolution, assessed up to 60 days', 'description': 'Ability of NEWS and qSOFA score to predict severity of bloodstream infection calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)'}, {'measure': 'Number of infections', 'timeFrame': 'From date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 days', 'description': 'Cumulative incidence of infections in patients with levofloxacin prophylaxis vs. patients without levofloxacin prophylaxis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', 'Sepsis score', 'National Early Warning Score (NEWS)', 'quick Sequential Organ Failure Assessment (qSOFA)', 'chemotherapy-induced febrile neutropenia', 'Antibiotics prophylaxis'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of sepsis scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients affected by Acute Myeloid Leukemia that had received between JAN2001 and DEC2019 an intensive chemotherapy cycle either as induction or consolidation regimen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of non M3 Acute Myeloid Leukemia according to WHO (World Health Organization) 2008 criteria\n* Age \\>= 18 years and \\<= 70 years\n* Patient had received intensive chemotherapy either as induction or consolidation regimen\n* Period of observation: January 2001 - December 2019\n* Written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of Acute Promyelocytic Leukemia (M3 AML)\n* Age \\< 18 or \\>70 years\n* Patient had not received intensive chemotherapy'}, 'identificationModule': {'nctId': 'NCT05249894', 'acronym': 'LAM-SEPSIS', 'briefTitle': 'Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of Sepsis Scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of Sepsis Scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy (LAM-SEPSIS)', 'orgStudyIdInfo': {'id': 'LAM-SEPSIS'}}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Frairia, MD', 'role': 'CONTACT'}], 'facility': 'AOU Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Chiara Frairia, MD', 'role': 'CONTACT', 'email': 'cfrairia@cittadellasalute.to.it', 'phone': '+390116335612'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor in Hematology', 'investigatorFullName': 'Chiara Frairia', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}