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Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation

Primary Purpose

Pneumonia, Staphylococcal, Methicillin-Resistant Staphylococcus Aureus

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vancomycin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Staphylococcal

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Nosocomial or severe community-acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus
  • Must be mechanically ventilated in intensive care unit

Exclusion Criteria:

  • Non-bacterial pneumonia, such as viral, fungal, tuberculosis infections
  • 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aerosolized Vancomycin

Arm Description

Outcomes

Primary Outcome Measures

clinical cure rate

Secondary Outcome Measures

the peak level of serum vancomycin level

Full Information

First Posted
August 15, 2013
Last Updated
April 21, 2019
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01925066
Brief Title
Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
Official Title
Optimal Two-Stage Phase 2 Study of Efficacy and Pharmacokinetics of Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Staphylococcal, Methicillin-Resistant Staphylococcus Aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerosolized Vancomycin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
250mg bid, Inhalation for 5-7 days
Primary Outcome Measure Information:
Title
clinical cure rate
Time Frame
within the first 30 days after treatment
Secondary Outcome Measure Information:
Title
the peak level of serum vancomycin level
Time Frame
on 3rd and 5th days after treatment
Other Pre-specified Outcome Measures:
Title
microbiological response
Time Frame
within the first 30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nosocomial or severe community-acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus Must be mechanically ventilated in intensive care unit Exclusion Criteria: Non-bacterial pneumonia, such as viral, fungal, tuberculosis infections 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Joon Yim, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
2702835
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.
Results Reference
background
PubMed Identifier
32050447
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.
Results Reference
derived
Links:
URL
http://linus.nci.nih.gov/brb/samplesize/otsd.html
Description
Optimal Two-Stage Designs For Phase II Clinical Trials

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Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation

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