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

Phase 2

Completed

• Conditions: Pneumonia, Staphylococcal; Methicillin-Resistant Staphylococcus Aureus
• Interventions: Drug: Vancomycin

• Registration Number: NCT01925066
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-21
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerosolized Vancomycin	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
clinical cure rate	within the first 30 days after treatment

Secondary Outcome Measures

Name	Time	Method
the peak level of serum vancomycin level	on 3rd and 5th days after treatment

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of