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

This study is currently recruiting participants.
Verified February 2017 by Seoul National University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01925066
First Posted: August 19, 2013
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital
  Purpose
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.

Condition Intervention Phase
Pneumonia, Staphylococcal Methicillin-Resistant Staphylococcus Aureus Drug: Vancomycin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Two-Stage Phase 2 Study of Efficacy and Pharmacokinetics of Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • clinical cure rate [ Time Frame: within the first 30 days after treatment ]

Secondary Outcome Measures:
  • the peak level of serum vancomycin level [ Time Frame: on 3rd and 5th days after treatment ]

Other Outcome Measures:
  • microbiological response [ Time Frame: within the first 30 days after treatment ]

Estimated Enrollment: 86
Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerosolized Vancomycin Drug: Vancomycin
Other Name: 250mg bid, Inhalation for 5-7 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925066


Contacts
Contact: Young-Jae Cho, MD +82-31-787-7058 lungdrcho@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Young-Jae Cho, MD    +82-31-787-7058    lungdrcho@gmail.com   
Principal Investigator: Young-Jae Cho, MD         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Study Director: Jae-Joon Yim, MD Seoul National University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01925066     History of Changes
Other Study ID Numbers: B-1206-156-004
First Submitted: August 15, 2013
First Posted: August 19, 2013
Last Update Posted: March 6, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Staphylococcal
Pneumonia, Bacterial
Staphylococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents