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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Seoul National University Hospital
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01925066
First received: August 15, 2013
Last updated: March 12, 2014
Last verified: March 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the peak level of serum vancomycin level [ Time Frame: on 3rd and 5th days after treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • microbiological response [ Time Frame: within the first 30 days after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: August 2013
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 15, 2013
Last Updated: March 12, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

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

ClinicalTrials.gov processed this record on November 27, 2014