Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-01 @ 5:16 PM
Study NCT ID:
NCT03925402
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2019-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077727', 'term': 'Ertapenem'}, {'id': 'D015780', 'term': 'Carbapenems'}], 'ancestors': [{'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 427}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2019-04-20', 'studyFirstSubmitQcDate': '2019-04-20', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30 days', 'description': 'death from any cause within 30 days after the blood culture with bacteraemia is drawn'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '90 days', 'description': 'death from any cause within the duration of admission with bacteraemia'}, {'measure': '14-day mortality', 'timeFrame': '14 days', 'description': 'death from any cause within 14 days after the blood culture with bacteraemia is drawn'}, {'measure': '90-day mortality', 'timeFrame': '90 days', 'description': 'death from any cause within 90 days after the blood culture with bacteraemia is drawn'}, {'measure': '• Length of stay', 'timeFrame': '90 days', 'description': 'Duration of admission with bacteraemia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacteremia', 'Infection, Bacterial']}, 'referencesModule': {'references': [{'pmid': '37252945', 'type': 'DERIVED', 'citation': 'Vasikasin V, Panuvatvanich B, Rawson TM, Holmes AH, Nasomsong W. Towards optimizing carbapenem selection in stewardship strategies: a prospective propensity score-matched study of ertapenem versus class 2 carbapenems for empirical treatment of third-generation cephalosporin-resistant Enterobacterales bacteraemia. J Antimicrob Chemother. 2023 Jul 5;78(7):1748-1756. doi: 10.1093/jac/dkad165.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.', 'detailedDescription': "There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years of age and older admitted to Phramongkutklao Hospital, and Ananda Mahidol Hospital with 3GCRE monomicrobial bacteremia will be prospectively identified. In given a patient, only the initial episode of 3GCRE monomicrobial bacteremia during the study period will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, either sex, ages 18 years or above\n* Patients with 3GCRE bacteremia\n* Patients admitted to any of the study sites\n\nExclusion Criteria:\n\n* Discontinuation of antibiotic due to transition to hospice care\n* Polymicrobial bacteremia\n* Empirical antibiotic after 24 hours of first evidence of bacteremia'}, 'identificationModule': {'nctId': 'NCT03925402', 'briefTitle': 'Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia', 'organization': {'class': 'OTHER', 'fullName': 'Phramongkutklao College of Medicine and Hospital'}, 'officialTitle': 'Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis', 'orgStudyIdInfo': {'id': 'AMED2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ertapenem', 'description': 'Patients who received ertapenem as an empirical antibiotic', 'interventionNames': ['Drug: Ertapenem']}, {'label': 'Other carbapenems', 'description': 'Patients who received carbapenems other than ertapenem as an empirical antibiotic', 'interventionNames': ['Drug: Carbapenems']}], 'interventions': [{'name': 'Ertapenem', 'type': 'DRUG', 'description': 'Ertapenem injection', 'armGroupLabels': ['Ertapenem']}, {'name': 'Carbapenems', 'type': 'DRUG', 'description': 'Other carbapenems injection', 'armGroupLabels': ['Other carbapenems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Phramongkutklao Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phramongkutklao College of Medicine and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}