Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01507532
Status:
WITHDRAWN
Last Update Posted:
2018-03-20
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002442', 'term': 'Ceftazidime'}], 'ancestors': [{'id': 'D002509', 'term': 'Cephaloridine'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'did not enroll a patient', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-17', 'studyFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine clearance of ceftazidime in hemodialysis', 'timeFrame': 'time 0 = end of infusion) up to 72 hours', 'description': 'Serial blood draws will be performed at the following times in hours (time 0 = end of infusion): the time immediately before hemodialysis, 0.5, 4, and immediately before the next dose of ceftazidime. Any extra blood from samples drawn by the primary provider per routine care during the study period will also be considered for capture if it would routinely be discarded. The blood draws for this study will occur over a period of 72 hours (i.e. until the day of the following hemodialysis session).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Failure']}, 'descriptionModule': {'briefSummary': 'Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous ceftazidime pharmacokinetics will be performed in patients undergoing intermittent hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in high flux hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours, who have end-stage renal disease and been receiving intermittent hemodialysis for at least 90 days.\n* Eligible patients will additionally have either central or peripheral intravenous access, and will already be prescribed ceftazidime per their primary providers.\n* Written informed consent in a form approved by Northwestern Memorial Hospital, Northwestern University Institutional Review Board, and Midwestern University Institutional Review Board will be completed by the patient prior to enrollment.\n\nExclusion Criteria:\n\n* Patients that only receive one dose of ceftazidime in total\n* Patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).\n* Not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01507532', 'briefTitle': 'Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Midwestern University'}, 'officialTitle': 'Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'STU00056702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ceftazidime', 'description': 'pharmacokinetic monitoring', 'interventionNames': ['Other: pharmacokinetic monitoring']}], 'interventions': [{'name': 'pharmacokinetic monitoring', 'type': 'OTHER', 'otherNames': ['Fortaz'], 'description': 'pharmacokinetic monitoring', 'armGroupLabels': ['Ceftazidime']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Marc H Scheetz, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marc Scheetz', 'investigatorAffiliation': 'Midwestern University'}}}}