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

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. Identifier: NCT01925066
Recruitment Status : Recruiting
First Posted : August 19, 2013
Last Update Posted : March 6, 2017
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Staphylococcal Methicillin-Resistant Staphylococcus Aureus Drug: Vancomycin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
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
Study Start Date : August 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA Pneumonia

Arm Intervention/treatment
Experimental: Aerosolized Vancomycin Drug: Vancomycin
Other Name: 250mg bid, Inhalation for 5-7 days

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01925066

Contact: Young-Jae Cho, MD +82-31-787-7058

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   
Principal Investigator: Young-Jae Cho, MD         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Study Director: Jae-Joon Yim, MD Seoul National University Hospital

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

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