Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT04388293
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2020-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Antibiotics Wisely - An Antimicrobial Stewardship Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-07', 'studyFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2020-05-10', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of therapy/1000 patient-day of each category of antimicrobial consumption', 'timeFrame': '2020-2025'}, {'measure': 'Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay', 'timeFrame': '2020-2025'}], 'secondaryOutcomes': [{'measure': 'Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.', 'timeFrame': '2020-2025'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antimicrobial Stewardship', 'Prematurity', 'Neonate'], 'conditions': ['Multi-Drug Resistant Organisms', 'Late-Onset Sepsis, Neonatal', 'Antimicrobial Resistance']}, 'referencesModule': {'references': [{'pmid': '33303471', 'type': 'DERIVED', 'citation': 'Ting JY, Roberts A, Tilley P, Robinson JL, Dunn MS, Paquette V, Lee KS, Shah V, Yoon E, Richter LL, Lodha A, Shivananda S, Thampi N, Autmizguine J, Shah PS; Canadian Neonatal Network Investigators. Development of a national neonatal intensive care unit-specific antimicrobial stewardship programme in Canada: protocol for a cohort study. BMJ Open. 2020 Dec 10;10(12):e043403. doi: 10.1136/bmjopen-2020-043403.'}]}, 'descriptionModule': {'briefSummary': 'There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.', 'detailedDescription': 'Purpose: The investigators aim to develop and implement NICU-specific Antimicrobial Stewardship Program (ASP) strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of multi-drug resistant organisms (MDRO) in Canada.\n\nHypothesis: The investigators expect to find:\n\n* Significant national variation in broad-spectrum antimicrobial use, which will not be correlated with rates of sepsis. High antimicrobial consumption rates may be associated with limited existing ASP resources and increased neonatal morbidity related to inflammatory cascades.\n* Significant national variation in the prevalence of MDROs across NICUs.\n* Differences in empirical antimicrobial regimens may be associated with MDRO prevalence, and the variation in antimicrobial use may explain some variation in neonatal morbidity.\n\nStudy Population and Sample Size: The study population will include very-low-birth-weight (VLBW) infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '44 Weeks', 'minimumAge': '22 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include all VLBW infants admitted to participating tertiary NICUs in Canada. The investigators will exclude infants with major congenital anomalies to avoid confounding factors when analyzing the impact of antimicrobial use and MDRO on neonatal outcomes. All VLBW infants will be included in the primary MDRO prevalence analysis. The investigators expect \\~2000 VLBW infants with culture-proven infections in the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Very-low-birth-weight infants admitted to participating tertiary NICUs in Canada.\n\nExclusion Criteria:\n\n* infants with major congenital anomalies'}, 'identificationModule': {'nctId': 'NCT04388293', 'briefTitle': 'Using Antibiotics Wisely - An Antimicrobial Stewardship Program', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Using Antibiotics Wisely - Development of National Neonatal Intensive Care Unit-specific ASP', 'orgStudyIdInfo': {'id': 'H19-02490'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Exposure of interest', 'type': 'OTHER', 'description': 'Very Low Birth Weight infants admitted to tertiary NICUs in Canada.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Joseph Ting, MD, MPH', 'role': 'CONTACT', 'email': 'joseph.ting@ualberta.ca', 'phone': '+1(780)248-5408'}], 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Joseph Ting, Associate Prof', 'role': 'CONTACT', 'email': 'joseph.ting@ualberta.ca', 'phone': '+1(780)248-5408'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, {'name': "Children's Hospital of Eastern Ontario", 'class': 'OTHER'}, {'name': 'Université de Montréal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joseph Ting', 'investigatorAffiliation': 'University of Alberta'}}}}