Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-07 @ 12:12 AM
Study NCT ID:
NCT03094494
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2017-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Carbapenem as Rescue Strategy for the Treatment of Carbapenemase-Producing Klebsiella Pneumoniae Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2017-03-23', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 day', 'description': 'mortality after 28 day from infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbapenem', 'Klebsiella Pneumonia']}, 'referencesModule': {'references': [{'pmid': '28679413', 'type': 'DERIVED', 'citation': 'De Pascale G, Martucci G, Montini L, Panarello G, Cutuli SL, Di Carlo D, Di Gravio V, Di Stefano R, Capitanio G, Vallecoccia MS, Polidori P, Spanu T, Arcadipane A, Antonelli M. Double carbapenem as a rescue strategy for the treatment of severe carbapenemase-producing Klebsiella pneumoniae infections: a two-center, matched case-control study. Crit Care. 2017 Jul 5;21(1):173. doi: 10.1186/s13054-017-1769-z.'}]}, 'descriptionModule': {'briefSummary': 'An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients with severe CR-Kp infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 18 years;\n2. ICU admission between November 2012 and December 2015;\n3. documented CR-Kp invasive infection;\n4. targeted antibiotic therapy lasting ≥ 72 hours\n\nExclusion Criteria\n\n1. Klebsiella infection, susceptible to carbapenems\n2. Duration of antimicrobial therapy less than 72 hours\n3. Data not completely available from the electronically medical chart'}, 'identificationModule': {'nctId': 'NCT03094494', 'briefTitle': 'Double Carbapenem as Rescue Strategy for the Treatment of Carbapenemase-Producing Klebsiella Pneumoniae Infections', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Double Carbapenem as Rescue Strategy for the Treatment of Severe Carbapenemase-Producing Klebsiella Pneumoniae Infections: A Two-Center Matched Case-Control Study', 'orgStudyIdInfo': {'id': 'UCSC14669/15 359/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Double Carbapenem Group', 'description': 'Patients underwent Double carbapenem treatment', 'interventionNames': ['Other: none intervention']}, {'label': 'Standard Treatment Group', 'description': 'Patients who were not treated with the double carbapenem', 'interventionNames': ['Other: none intervention']}], 'interventions': [{'name': 'none intervention', 'type': 'OTHER', 'description': 'none intervention', 'armGroupLabels': ['Double Carbapenem Group', 'Standard Treatment Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Gennaro De Pascale', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}