Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT03114358
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbapenems De-escalation as Antimicrobial Stewardship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of de-escalation within the first 24 hour', 'timeFrame': '24 hours', 'description': 'Compare the rate of de-escalation within the first 24 hour between arm 1 and arm 2'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '90 days', 'description': 'Compare the mortality rate between 2 groups'}, {'measure': 'Readmission within 30 days,', 'timeFrame': '30 days', 'description': 'Compare the rate of readmission within 30 days between 2 groups'}, {'measure': 'Costs of carbapenems', 'timeFrame': '30 days', 'description': 'Compare the cost of carbapenem prescription between 2 groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['De-escalation', 'Carbapenems', 'Antimicrobial stewardship'], 'conditions': ['Anti-Bacterial Agents']}, 'descriptionModule': {'briefSummary': 'Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes', 'detailedDescription': 'A cluster randomized control trial was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital.\n\nPatients were randomly assigned into 2 groups. The standard group followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team. The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).\n\nClinical outcomes included rate of de-escalation within the first 24 hour, the mortality rate, and other clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* All adult patients aged ≥ 15 years old\n* received carbapenems (meropenem and imipenem/cilastatin) empirically within 24-72 hours for the first time during admission\n* able to sign informed consent\n\nExclusion criteria\n\n* They were in the intensive care units, or had neutropenia (absolute neutrophil count \\< 1,000 cell/mm3)'}, 'identificationModule': {'nctId': 'NCT03114358', 'briefTitle': 'Carbapenems De-escalation as Antimicrobial Stewardship', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'A Cluster Randomized Controlled Trial Comparing Early and Late Carbapenems De-escalation in the Medicine Units, Maharaj Nakorn Chiang Mai Hospital', 'orgStudyIdInfo': {'id': '3629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early carbapenems de-escalation', 'description': 'De-escalation carbapenems within 24 hours or no later than 72 hours of prescription by Infectious disease specialist (early de-escalation).', 'interventionNames': ['Other: Early Carbapenem de-escalation']}, {'type': 'NO_INTERVENTION', 'label': 'Late carbapenems de-escalation', 'description': 'De-escalation followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team'}], 'interventions': [{'name': 'Early Carbapenem de-escalation', 'type': 'OTHER', 'description': 'The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).', 'armGroupLabels': ['Early carbapenems de-escalation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Romanee Chaiwarith', 'investigatorAffiliation': 'Chiang Mai University'}}}}