Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-02-22 @ 9:36 AM
Study NCT ID:
NCT03968328
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}, {'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '14 day cause specific mortality rate', 'timeFrame': 'At 14 days', 'description': 'Will perform univariate logistic regression analysis to assess the effect of time to antibiotic administration on death 14 days post fever onset. Will build multivariate logistic regression model(s) to further assess the effect of time to antibiotic administration on death 14 days post fever onset adjusting for other potential confounders.'}], 'secondaryOutcomes': [{'measure': 'Cause specific death', 'timeFrame': 'Up to 5 years'}, {'measure': 'Intensive care unit (ICU) admission rate', 'timeFrame': 'Up to 5 years'}, {'measure': 'ICU length of stay', 'timeFrame': 'Up to 5 years', 'description': 'Linear regression model will be used to assess the multivariate relationship between time to antibiotic administration, patient demographic and clinical characteristics with ICU length of stay.'}, {'measure': 'Length of hospitalization', 'timeFrame': 'Up to 5 years', 'description': 'Linear regression model will be used to assess the multivariate relationship between time to antibiotic administration, patient demographic and clinical characteristics with length of hospitalization.'}, {'measure': 'Percentage of patients with positive blood cultures', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Febrile Neutropenia', 'Fever']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This trial uses an interview and a survey to gather information from cancer patients about the onset of their fever and the administration of antibiotics. Collecting information from patients may help doctors to assess the relationship between time to antibiotic administration and inhospital cause specific death, intensive care unit admission, hospital length of stay, and positive blood cultures.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the prognostic value of the length of time between the time onset of fever and first antibiotic administration on cause specific 14 day mortality rate.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the associations of the length of time between the time onset of fever and first antibiotic administration with intensive care unit (ICU) admission, ICU length of stay, length of hospitalization and percentage of patients with positive blood cultures.\n\nOUTLINE:\n\nPatients respond to a survey and participate in an interview with study staff about their fever and when they started feeling unwell.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at the University of Texas MD Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'IInclusion criteria:\n\n--\\> 18 years of age\n\n* Temperature above 38.0 documented\n* ANC\\< 500/mm3\n\nExclusion Criteria:\n\n--Age \\<18'}, 'identificationModule': {'nctId': 'NCT03968328', 'briefTitle': 'Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'The Prognostic Value of the Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients', 'orgStudyIdInfo': {'id': '2015-0272'}, 'secondaryIdInfos': [{'id': 'NCI-2019-02655', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2015-0272', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (interview, survey)', 'description': 'Patients respond to a survey and participate in an interview with study staff about their fever and when they started feeling unwell.', 'interventionNames': ['Other: Interview', 'Other: Survey Administration']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': 'Take part in interview', 'armGroupLabels': ['Observational (interview, survey)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Respond to survey', 'armGroupLabels': ['Observational (interview, survey)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sai-ching Yeung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}