Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT01295606
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2010-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-02-19', 'releaseDate': '2013-01-16'}, {'resetDate': '2015-11-18', 'releaseDate': '2015-10-19'}, {'resetDate': '2016-06-17', 'releaseDate': '2016-05-11'}, {'resetDate': '2022-08-04', 'releaseDate': '2022-07-07'}], 'estimatedResultsFirstSubmitDate': '2013-01-16'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'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': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-12', 'studyFirstSubmitDate': '2010-12-07', 'studyFirstSubmitQcDate': '2011-02-11', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of iv cefazolin in neonates', 'timeFrame': 'up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration)'}], 'secondaryOutcomes': [{'measure': 'Optimalisation of cefazolin dose regimen during neonatal life', 'timeFrame': 'up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cefazolin', 'prophylaxis', 'pharmacokinetics', 'newborn'], 'conditions': ['Prophylaxis']}, 'referencesModule': {'references': [{'pmid': '34499720', 'type': 'DERIVED', 'citation': 'Elkayal O, Allegaert K, Spriet I, Smits A, Seghaye MC, Charlier C, Dreesen E. Population pharmacokinetics of cefazolin in maternal and umbilical cord plasma, and simulated exposure in term neonates. J Antimicrob Chemother. 2021 Nov 12;76(12):3229-3236. doi: 10.1093/jac/dkab329.'}]}, 'descriptionModule': {'briefSummary': 'To document cefazolin disposition (concentration/time profile, protein binding, metabolism, renal elimination characteristics) and its covariates in neonates following intravenous administration of the drug at induction of anesthesia, prior to an invasive procedure\n\nTo evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed', 'detailedDescription': 'Prospective, single-center, open label study on the pharmacokinetics of iv cefazolin administration in neonates admitted in the neonatal intensive care unit, University Hospitals Leuven, Belgium.\n\nPatients will be included after signed informed consent of the parents.\n\nOur aim is to include 40 neonates. Cefazolin has been selected for this study as it is routinely administered in neonates undergoing invasive procedures in our unit. At this stage, we only have the intention to document pharmacokinetics and covariates based on the current clinical practice and therefore will not interfere with either clinical indication, or with dosing as prescribed by the attending physician.\n\nDrug administration and collection of samples will be obtained to the current clinical and nursing standard procedures.\n\nRoutine clinical care for scheduled invasive procedures in neonates in our unit is intravenous administration of cefazolin as follows:\n\n* 50 mg/kg, 3 times a day\n* an extra dose of 50mg/kg is given after 3 hours for operations longer than 3 h\n* each time one dose/day is excluded for neonates with body weight \\<2000 g and postnatal age (PNA) \\<7 days,\n* for invasive operations (e.g. open-heart surgery, laparotomy) the prophylactic administration of cefazolin may be continued for 3-5 days following the completion of surgery.\n\nThe antibiotic agent should be administered 30 minutes to 1 hour prior to the start of surgery so that adequate antibiotic levels. Cefazolin is administered to the neonate, through a peripherally inserted venous catheter, during 30 minutes.\n\nBlood will be collected in heparinised tubes through an indwelling arterial line, or deep venous access, always when other routine blood samples are collected for clinical purposes (pO2, pCO2, pH).\n\nUrine samples will be collected through a bladder catheter in patients in whom a bladder catheter is available for clinical indications.\n\nPharmacokinetic analysis A population pharmacokinetics approach will be used, hereby comparing the data on PK already reported in adults or older children and the newly collected data during neonatal life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed parental informed written consent\n* neonates to whom cefazolin is administered by intravenous route for clinical indications (invasive procedure)\n\nExclusion Criteria:\n\n* known cefazolin intolerance'}, 'identificationModule': {'nctId': 'NCT01295606', 'briefTitle': 'Cefazolin Pharmacokinetics: Elimination Clearance in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Cefazolin Pharmacokinetics: Elimination Clearance in Neonates', 'orgStudyIdInfo': {'id': 'S52907'}, 'secondaryIdInfos': [{'id': '2010-024319-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Cefazolin, antibiotic prophylaxis', 'description': 'All included patients will received iv cefazolin', 'interventionNames': ['Drug: Cefazolin']}], 'interventions': [{'name': 'Cefazolin', 'type': 'DRUG', 'otherNames': ['Kefzol'], 'description': 'iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment', 'armGroupLabels': ['Cefazolin, antibiotic prophylaxis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Karel Allegaert, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-01-16', 'type': 'RELEASE'}, {'date': '2013-02-19', 'type': 'RESET'}, {'date': '2015-10-19', 'type': 'RELEASE'}, {'date': '2015-11-18', 'type': 'RESET'}, {'date': '2016-05-11', 'type': 'RELEASE'}, {'date': '2016-06-17', 'type': 'RESET'}, {'date': '2022-07-07', 'type': 'RELEASE'}, {'date': '2022-08-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Universitaire Ziekenhuizen KU Leuven'}}}}