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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01925066

Enrollment

Registered

2013-08-19

Start date

2013-08-31

Completion date

2017-12-31

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-Resistant Staphylococcus Aureus, Pneumonia, Staphylococcal

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.

Interventions

DRUGVancomycin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
clinical cure rate	within the first 30 days after treatment

Secondary

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

Other

Measure	Time frame
microbiological response	within the first 30 days after treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026