Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01581333
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2012-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-02-02', 'size': 884323, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2017-10-20T06:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2012-04-17', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days on which patient is free of antimicrobial treatment', 'timeFrame': '28 days following the initiation of empiric antibiotic treatment.', 'description': 'Protocol visits: Screening visit, Randomization visit, at 72h. of apyrexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit).'}], 'secondaryOutcomes': [{'measure': 'Crude mortality', 'timeFrame': '28 days following the initiation of empiric antibiotic treatment.', 'description': 'Number of died patients'}, {'measure': 'Number of days of fever', 'timeFrame': '28 days following the initiation of empiric antibiotic treatment', 'description': 'Number of days of fever'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['febrile neutropenia', 'antimicrobial treatment', 'procalcitonin'], 'conditions': ['Febrile Neutropenia']}, 'referencesModule': {'references': [{'pmid': '29153975', 'type': 'DERIVED', 'citation': 'Aguilar-Guisado M, Espigado I, Martin-Pena A, Gudiol C, Royo-Cebrecos C, Falantes J, Vazquez-Lopez L, Montero MI, Rosso-Fernandez C, de la Luz Martino M, Parody R, Gonzalez-Campos J, Garzon-Lopez S, Calderon-Cabrera C, Barba P, Rodriguez N, Rovira M, Montero-Mateos E, Carratala J, Perez-Simon JA, Cisneros JM. Optimisation of empirical antimicrobial therapy in patients with haematological malignancies and febrile neutropenia (How Long study): an open-label, randomised, controlled phase 4 trial. Lancet Haematol. 2017 Dec;4(12):e573-e583. doi: 10.1016/S2352-3026(17)30211-9. Epub 2017 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).', 'detailedDescription': 'The optimal duration of the empirical antimicrobial therapy (AT) in hematological patients with febrile neutropenia (FN) is unknown. The Infectious Diseases Society of America (IDSA) recommends maintaining AT at least until the neutropenia is recovered, because literally "years of experience have proven this approach to be safe and effective". This recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by IDSA. The main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical AT in hematological patients with FN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Fever with etiologic diagnosis.\n* Patients with epilepsy.\n* Pregnant or lactating women.\n* Patients with HIV infection.\n* Patients with severe renal failure.'}, 'identificationModule': {'nctId': 'NCT01581333', 'acronym': 'HOWLONG', 'briefTitle': 'Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia', 'orgStudyIdInfo': {'id': '2011-005152-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Empirical antimicrobial treatment discontinuation', 'interventionNames': ['Drug: Empirical antimicrobial treatment discontinuation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Standard empirical antimicrobial treatment discontinuation', 'interventionNames': ['Drug: Standard empirical antimicrobial treatment discontinuation']}], 'interventions': [{'name': 'Empirical antimicrobial treatment discontinuation', 'type': 'DRUG', 'otherNames': ['Clinical rules for finalization of antimicrobial therapy'], 'description': 'Empirical antimicrobial treatment discontinuation will occur when the patient is: Afebrile, with resolution of signs, symptoms and test abnormalities secondary to complementary source of infection and with normalization of vital signs for ≥ 72 h.', 'armGroupLabels': ['Experimental Arm']}, {'name': 'Standard empirical antimicrobial treatment discontinuation', 'type': 'DRUG', 'otherNames': ['Laboratory rules for finalization of antimicrobial therapy'], 'description': 'The empirical antimicrobial treatment discontinuation will occur when the patient is:\n\nThe neutrophil count is above 500 million per mm3.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital de Jerez', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Bellvitge University Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Virgen del Rocío University Hospital', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'José M Cisneros Herreros, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}