Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT01669005
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '3 ml of EDTA-blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-17', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-17', 'lastUpdatePostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neutropenia', 'multiplex PCR', 'infection'], 'conditions': ['Neutropenia']}, 'descriptionModule': {'briefSummary': 'Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.\n\nHypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for multiplex PCR at admission and 3x/week thereafter until discharge or recovery from neutropenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the bone marrow transplant unit in the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged ≥18 years\n* autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed\n\nExclusion Criteria:\n\n* No blood samples were taken'}, 'identificationModule': {'nctId': 'NCT01669005', 'acronym': 'MedIso', 'briefTitle': 'The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study', 'orgStudyIdInfo': {'id': 'EK 324/06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bone marrow transplant unit patients', 'description': 'hospitalized patients in the bone marrow transplant unit for an autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andrej Trampuz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Lausanne, Switzerland'}, {'name': 'Christina Orasch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Lausanne, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrej Trampuz', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}