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Completed

NCT Number: NCT01925066

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.

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Key information

Conditions

Pneumonia, Staphylococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Methicillin-Resistant Staphylococcus Aureus Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Staphylococcal Infections

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

Other names: 250mg bid, Inhalation for 5-7 days

Primary outcomes

  1. clinical cure rate

    Time frame: within the first 30 days after treatment

Secondary outcomes

  1. the peak level of serum vancomycin level

    Time frame: on 3rd and 5th days after treatment

Other outcomes

  1. microbiological response

    Time frame: within the first 30 days after treatment

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 19, 2013
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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