Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT02417168
Status:
TERMINATED
Last Update Posted:
2020-03-04
First Post:
2015-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI left study site', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-10', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in procalcitonin levels', 'timeFrame': '24 hours', 'description': 'Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission.'}], 'secondaryOutcomes': [{'measure': 'The presence of bacteremia', 'timeFrame': '1 week', 'description': 'Blood will be cultured for bacteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer', 'Bacteremia']}, 'descriptionModule': {'briefSummary': 'Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result.\n\nThus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment.\n\nIn our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children between the ages of birth to seventeen years who have an existing oncologic diagnosis and who present with fever to Charleston Area Medical Center Women and Children's Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children between the ages of birth to seventeen years.\n* Present to Charleston Area Medical Center Women and Children's Hospital\n* Existing pediatric oncology diagnosis.\n* Temperature greater than 38.0 C or 100.5 Fahrenheit.\n* Central venous access or functional port available.\n\nExclusion Criteria:\n\n* Any non-pediatric (eighteen years and above) oncology patient or a non-oncology patient.\n* The patient does not have central venous access or a port from which the blood can be drawn."}, 'identificationModule': {'nctId': 'NCT02417168', 'briefTitle': 'Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'CAMC Health System'}, 'officialTitle': 'Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients - Pilot Study', 'orgStudyIdInfo': {'id': '14-42'}}, 'contactsLocationsModule': {'locations': [{'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'CAMC Health Systems', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CAMC Health System', 'class': 'OTHER'}, 'collaborators': [{'name': "CureSearch for Children's Cancer", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}