Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-01 @ 3:20 AM
Study NCT ID:
NCT01797133
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2013-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 984}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2013-02-17', 'studyFirstSubmitQcDate': '2013-02-20', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical response', 'timeFrame': 'at the end of therapy and at discharge (an average duration of antibiotic therapy is 2 weeks, an average length of stay is 3 weeks)', 'description': 'Clinial response (cure, improved, not improved, dead and refer) at the end of therapy and at discharge'}], 'primaryOutcomes': [{'measure': 'Defined Daily Dose (DDD) of antibiotics', 'timeFrame': 'Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks', 'description': 'DDD of antibiotic use for that given infection (all antibiotics and controlled antibiotics)'}], 'secondaryOutcomes': [{'measure': 'Total duration of antibiotic use', 'timeFrame': 'Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks', 'description': 'Total duration of antibiotic use for that given infection (all antibiotics and controlled antibiotics)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['All Hospitalzied Patients', 'No Specific Conditions Requires']}, 'referencesModule': {'references': [{'pmid': '30156171', 'type': 'DERIVED', 'citation': 'Rattanaumpawan P, Upapan P, Thamlikitkul V. A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows. Infect Control Hosp Epidemiol. 2018 Oct;39(10):1154-1162. doi: 10.1017/ice.2018.198. Epub 2018 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'We will conduct a cluster randomized controlled trial to compare two antibiotic pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and duration of antibiotic consumption would be lower in the pharmacist group while the clinical outcome would be equivalent between two groups.', 'detailedDescription': 'Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients\n* Received at least one dose of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem or Doripenem)\n* Each patient may be enrolled more than once, if he/she receives the controlled antibiotic for a new episode of infection (at least 48 hour apart)\n\nExclusion Criteria:\n\n* Died prior to receive the controlled antibiotic'}, 'identificationModule': {'nctId': 'NCT01797133', 'acronym': 'DUE', 'briefTitle': 'A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures', 'orgStudyIdInfo': {'id': '647/2555(EC1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fellow arm', 'description': 'Patients in this arm will receive the ID fellow-based antibiotic pre-authorization intervention.', 'interventionNames': ['Procedure: ID fellow-based antibiotic pre-authorization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacist arm', 'description': 'Patients in this arm will receive the pharmacist-based antibiotic pre-authorization intervention.', 'interventionNames': ['Procedure: Pharmacist-based antibiotic pre-authorization']}], 'interventions': [{'name': 'ID fellow-based antibiotic pre-authorization', 'type': 'PROCEDURE', 'description': 'All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by ID-fellows, under the supervision of ID staffs.', 'armGroupLabels': ['Fellow arm']}, {'name': 'Pharmacist-based antibiotic pre-authorization', 'type': 'PROCEDURE', 'description': 'All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by general pharmacists, under the supervision of ID staffs.', 'armGroupLabels': ['Pharmacist arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Pinyo Rattanaumpawan, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mahidol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asssitant Professor', 'investigatorFullName': 'Pinyo Rattanaumpawan', 'investigatorAffiliation': 'Siriraj Hospital'}}}}