Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-09 @ 11:40 AM
Study NCT ID:
NCT02007603
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2013-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concentration of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid in the Blood During Renal Replacement Therapy in Longterm Renal Replacement Therapy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'C035444', 'term': 'sultamicillin'}], 'ancestors': [{'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-29', 'studyFirstSubmitDate': '2013-10-16', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels.', 'timeFrame': 'day 15', 'description': 'Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic hemodialysis', 'ampicillin', 'sulbactam', 'amoxicillin', 'clavulanic acid', 'pharmacokinetics'], 'conditions': ['Infection During Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and amoxicillin/clavulanic acid during intermittent haemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Suspected or proven bacterial infection requiring parenteral antibiotic therapy.\n* Renal replacement therapy (HD)\n\nExclusion Criteria:\n\n* Known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.\n* An expected survival of less than two days.\n* Known pregnancy\n* Co-administration of one of the following drugs: probenecid which cannot be discontinued for the duration of the study\n* Ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections.\n* Other reasons opposing the study participation on the discretion of the investigators.'}, 'identificationModule': {'nctId': 'NCT02007603', 'briefTitle': 'Concentration of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid in the Blood During Renal Replacement Therapy in Longterm Renal Replacement Therapy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients', 'orgStudyIdInfo': {'id': 'AMPISUL/AMOXICLAV-HD_V1.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ampicillin / sulbactam', 'description': 'Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.', 'interventionNames': ['Drug: Ampicillin / sulbactam', 'Procedure: Blooddraws for pharmacokinetic profiling']}, {'type': 'EXPERIMENTAL', 'label': 'Amoxicillin / clavulanic acid', 'description': 'Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.', 'interventionNames': ['Drug: Administration of Amoxicillin / clavulanic acid', 'Procedure: Blooddraws for pharmacokinetic profiling']}], 'interventions': [{'name': 'Administration of Amoxicillin / clavulanic acid', 'type': 'DRUG', 'description': 'Patients receive amoxicillin / clavulanic acid due to clinical necessity', 'armGroupLabels': ['Amoxicillin / clavulanic acid']}, {'name': 'Ampicillin / sulbactam', 'type': 'DRUG', 'description': 'Patients receive ampicillin / sulbactam due to clinical necessity', 'armGroupLabels': ['Ampicillin / sulbactam']}, {'name': 'Blooddraws for pharmacokinetic profiling', 'type': 'PROCEDURE', 'description': 'Blood will be sampled at multiple timepoints during multiple hemodialysis sessions', 'armGroupLabels': ['Amoxicillin / clavulanic acid', 'Ampicillin / sulbactam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Florian Thalhammer, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'a.o.Univ.-Prof. Dr.', 'investigatorFullName': 'Florian Thalhammer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}