Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT02287493
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ch.koenig@uke.de', 'phone': '+49 040 7410 -0', 'title': 'Dr. Christina König', 'organization': 'University Medical Center Hamburg-Eppendorf'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Mortality was not considered to be a Serious Adverse Event.', 'description': 'Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.\n\nMortality was not considered to be a Serious Adverse Event.', 'eventGroups': [{'id': 'EG000', 'title': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.\n\nPharmacokinetic Analysis'}, {'id': 'OG001', 'title': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.\n\nPharmacokinetic Analysis'}], 'classes': [{'title': 'Trough level < MIC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Trough level > MIC', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'days receiving SLED, up to 5 days', 'description': 'Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections.\n\nTherefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.\n\nPharmacokinetic Analysis'}, {'id': 'OG001', 'title': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.\n\nPharmacokinetic Analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'minimum duration of hospital stay, maximum 1 year', 'description': 'ICU mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.'}, {'id': 'OG001', 'title': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.'}], 'classes': [{'title': 'LOS in hospital', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '264'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '264'}]}]}, {'title': 'LOS in ICU', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '264'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '264'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'minimum duration of hospital stay, maximum 1 year', 'description': 'Length of stay at the ICU and in hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinical Cure of Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed'}, {'id': 'OG001', 'title': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'minimum duration of hospital stay, maximum 1 year', 'description': 'Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.'}, {'id': 'FG001', 'title': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.'}, {'id': 'BG001', 'title': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '74'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '67'}, {'value': '64.5', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2014-10-30', 'resultsFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2014-11-05', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-31', 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)', 'timeFrame': 'days receiving SLED, up to 5 days', 'description': 'Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections.\n\nTherefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'minimum duration of hospital stay, maximum 1 year', 'description': 'ICU mortality'}, {'measure': 'Length of Stay (LOS)', 'timeFrame': 'minimum duration of hospital stay, maximum 1 year', 'description': 'Length of stay at the ICU and in hospital'}, {'measure': 'Number of Patients With Clinical Cure of Infections', 'timeFrame': 'minimum duration of hospital stay, maximum 1 year', 'description': 'Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Replacement Therapy, Renal']}, 'referencesModule': {'references': [{'pmid': '29382394', 'type': 'DERIVED', 'citation': 'Braune S, Konig C, Roberts JA, Nierhaus A, Steinmetz O, Baehr M, Kluge S, Langebrake C. Pharmacokinetics of meropenem in septic patients on sustained low-efficiency dialysis: a population pharmacokinetic study. Crit Care. 2018 Jan 30;22(1):25. doi: 10.1186/s13054-018-1940-1.'}]}, 'descriptionModule': {'briefSummary': 'In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.', 'detailedDescription': 'Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC).\n\nPrimary endpoint:\n\n\\- Plasma levels of antiinfectives during SLED\n\nSecondary endpoints:\n\n* mortality\n* length of stay at the intensive care unit (ICU) and hospital\n* clinical cure of infections\n\nInclusion criteria:\n\n* age: \\> 18 years\n* patients under SLED\n* antiinfective treatment\n\nexclusion criteria:\n\n\\- missing informed consent'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ICU patients at University Medical Center Hamburg-Eppendorf receiving SLED and either meropenem or ceftazidim.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18 or older\n* patients receiving SLED and either meropenem or ceftazidim\n\nExclusion Criteria:\n\n* missing informed consent'}, 'identificationModule': {'nctId': 'NCT02287493', 'acronym': 'PhA-SLED', 'briefTitle': 'Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)', 'orgStudyIdInfo': {'id': 'PV4244'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Meropenem', 'description': 'Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.', 'interventionNames': ['Other: Pharmacokinetic Analysis']}, {'label': 'Ceftazidim', 'description': 'Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.', 'interventionNames': ['Other: Pharmacokinetic Analysis']}], 'interventions': [{'name': 'Pharmacokinetic Analysis', 'type': 'OTHER', 'armGroupLabels': ['Ceftazidim', 'Meropenem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Stefan Kluge, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Clinical Research Hospital Pharmacy', 'investigatorFullName': 'PD Dr. rer. medic. Claudia Langebrake', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}