Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-04-16 @ 1:44 AM
Study NCT ID:
NCT01925066
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2013-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-30', 'releaseDate': '2021-04-07'}], 'estimatedResultsFirstSubmitDate': '2021-04-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011023', 'term': 'Pneumonia, Staphylococcal'}], 'ancestors': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-21', 'studyFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'microbiological response', 'timeFrame': 'within the first 30 days after treatment'}], 'primaryOutcomes': [{'measure': 'clinical cure rate', 'timeFrame': 'within the first 30 days after treatment'}], 'secondaryOutcomes': [{'measure': 'the peak level of serum vancomycin level', 'timeFrame': 'on 3rd and 5th days after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pneumonia, Staphylococcal', 'Methicillin-Resistant Staphylococcus Aureus']}, 'referencesModule': {'references': [{'pmid': '2702835', 'type': 'BACKGROUND', 'citation': 'Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.'}, {'pmid': '32050447', 'type': 'DERIVED', 'citation': 'Cho JY, Kim HS, Yang HJ, Lee YJ, Park JS, Yoon HI, Kim HB, Yim JJ, Lee JH, Lee CT, Cho YJ. Pilot Study of Aerosolised Plus Intravenous Vancomycin in Mechanically Ventilated Patients with Methicillin-Resistant Staphylococcus Aureus Pneumonia. J Clin Med. 2020 Feb 9;9(2):476. doi: 10.3390/jcm9020476.'}], 'seeAlsoLinks': [{'url': 'http://linus.nci.nih.gov/brb/samplesize/otsd.html', 'label': 'Optimal Two-Stage Designs For Phase II Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether aerosolized vancomycin is effective in the treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nosocomial or severe community-acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus\n* Must be mechanically ventilated in intensive care unit\n\nExclusion Criteria:\n\n* Non-bacterial pneumonia, such as viral, fungal, tuberculosis infections\n* Underlying respiratory condition: bronchiectasis, post-tuberculosis, chronic obstructive pulmonary disease or asthma\n* Complicated pneumonia, such as empyema, parapneumonic effusion requiring chest tube or drainage\n* Already or previous treated with intravenous vancomycin (Not pneumonia)\n* Adverse reaction due to inhaled ventolin before treatment of aerosolized vancomycin\n* Hypersensitivity of vancomycin or glycopeptide antibiotics\n* Positive culture of Enterococcus in respiratory specimen\n* Pregnant or Breast-feeding patient\n* Immunocompromised hosts: more than 1mg/kg of corticosteroid users for more than 3 months, transplantation recipients, AIDS patients\n* Another aerosolized antibiotics within 48 hours of study enrollment\n* Not adherent to mechanical ventilation protocol of this study\n* Not arterial line monitoring\n* Vancomycin minimum inhibitory concentration \\>= 2㎍/㎖ of cultured Staphylococcus aureus'}, 'identificationModule': {'nctId': 'NCT01925066', 'briefTitle': 'Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Optimal Two-Stage Phase 2 Study of Efficacy and Pharmacokinetics of Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'B-1206-156-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerosolized Vancomycin', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['250mg bid, Inhalation for 5-7 days'], 'armGroupLabels': ['Aerosolized Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jae-Joon Yim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-04-07', 'type': 'RELEASE'}, {'date': '2021-04-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Seoul National University Hospital'}}}}