Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
NCT ID: NCT01925066
Last Updated: 2019-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2013-08-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aerosolized Vancomycin
Vancomycin
Interventions
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Vancomycin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be mechanically ventilated in intensive care unit
Exclusion Criteria
* Underlying respiratory condition: bronchiectasis, post-tuberculosis, chronic obstructive pulmonary disease or asthma
* Complicated pneumonia, such as empyema, parapneumonic effusion requiring chest tube or drainage
* Already or previous treated with intravenous vancomycin (Not pneumonia)
* Adverse reaction due to inhaled ventolin before treatment of aerosolized vancomycin
* Hypersensitivity of vancomycin or glycopeptide antibiotics
* Positive culture of Enterococcus in respiratory specimen
* Pregnant or Breast-feeding patient
* Immunocompromised hosts: more than 1mg/kg of corticosteroid users for more than 3 months, transplantation recipients, AIDS patients
* Another aerosolized antibiotics within 48 hours of study enrollment
* Not adherent to mechanical ventilation protocol of this study
* Not arterial line monitoring
* Vancomycin minimum inhibitory concentration \>= 2㎍/㎖ of cultured Staphylococcus aureus
19 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jae-Joon Yim, MD
Role: STUDY_DIRECTOR
Seoul National University Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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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.
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.
Related Links
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Optimal Two-Stage Designs For Phase II Clinical Trials
Other Identifiers
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B-1206-156-004
Identifier Type: -
Identifier Source: org_study_id
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