Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-26 @ 11:03 AM
Study NCT ID:
NCT02210169
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2014-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-31', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Drug-related adverse effects', 'timeFrame': '2 years', 'description': 'the proportion of drug-related adverse effects with CIV compared to IIV'}, {'measure': 'Time to achieve target levels', 'timeFrame': '2 years', 'description': 'the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood'}, {'measure': 'Clearance of vancomycin in young infants', 'timeFrame': '2 years', 'description': 'Population pharmacokinetic modelling of vancomycin in young infants using NONMEM'}, {'measure': 'Volume of distribution of vancomycin in young infants', 'timeFrame': '2 years', 'description': 'Population pharmacodynamics modelling of vancomycin in young infants using NONMEM'}, {'measure': 'Area under the concentration-time curve of vancomycin in young infants', 'timeFrame': '2 years', 'description': 'Population pharmacodynamics modelling of vancomycin in young infants using NONMEM'}, {'measure': 'Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants', 'timeFrame': '2 years', 'description': 'Population pharmacodynamics modelling of vancomycin in young infants using NONMEM'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sepsis', 'Infection', 'Bacteremia']}, 'referencesModule': {'references': [{'pmid': '30700564', 'type': 'DERIVED', 'citation': 'Gwee A, Cranswick N, McMullan B, Perkins E, Bolisetty S, Gardiner K, Daley A, Ward M, Chiletti R, Donath S, Hunt R, Curtis N. Continuous Versus Intermittent Vancomycin Infusions in Infants: A Randomized Controlled Trial. Pediatrics. 2019 Feb;143(2):e20182179. doi: 10.1542/peds.2018-2179.'}, {'pmid': '30391914', 'type': 'DERIVED', 'citation': 'Gwee A, Cranswick N, Donath SM, Hunt R, Curtis N. Protocol for a randomised controlled trial of continuous infusions of vancomycin to improve the attainment of target vancomycin levels in young infants: The VANC trial. BMJ Open. 2018 Nov 3;8(11):e022603. doi: 10.1136/bmjopen-2018-022603.'}]}, 'descriptionModule': {'briefSummary': 'Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering vancomycin as a continuous infusion will result in improved attainment of target concentrations in blood at steady state (when the drug is in equilibrium) compared to intermittent infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.\n\nExclusion Criteria:\n\n* Infants with a corrected gestational age \\< 25 weeks.\n* Allergy to vancomycin or other glycopeptide antibiotic\n* Vancomycin administered within the previous 72 hours\n* Renal impairment\n* Prior enrolment in the study\n* Need for drug that is incompatible with vancomycin (if no other IV line is available)'}, 'identificationModule': {'nctId': 'NCT02210169', 'briefTitle': 'RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Murdoch Childrens Research Institute'}, 'officialTitle': 'A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates', 'orgStudyIdInfo': {'id': 'Vanc_IIV vs CIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Intermittent infusion of vancomycin', 'description': 'Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous infusion of vancomycin', 'description': 'A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.', 'interventionNames': ['Drug: Continuous infusion of vancomycin']}], 'interventions': [{'name': 'Continuous infusion of vancomycin', 'type': 'DRUG', 'description': 'Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.', 'armGroupLabels': ['Continuous infusion of vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Hospital for Women', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3052', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "The Royal Children's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Amanda Gwee, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Murdoch Childrens Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Murdoch Childrens Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Royal Children's Hospital", 'class': 'OTHER'}, {'name': 'Royal Hospital For Women', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}