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

Optimal Two-Stage Phase 2 Study of Efficacy and Pharmacokinetics of Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation

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.

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