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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Staphylococcal; Methicillin-Resistant Staphylococcus Aureus

Intervention: Vancomycin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jae-Joon Yim, MD, Study Director, Affiliation: Seoul National University Hospital

Overall contact:
Young-Jae Cho, MD, Phone: +82-31-787-7058, Email: lungdrcho@gmail.com

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: clinical cure rate

Secondary outcome: the peak level of serum vancomycin level

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Young-Jae Cho, MD, Phone: +82-31-787-7058, Email: lungdrcho@gmail.com

Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, Korea, Republic of; Recruiting
Young-Jae Cho, MD, Phone: +82-31-787-7058, Email: lungdrcho@gmail.com
Young-Jae Cho, MD, Principal Investigator
Additional Information

Optimal Two-Stage Designs For Phase II Clinical Trials

Related publications:

Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10.

Starting date: August 2013
Last updated: April 13, 2015

Page last updated: August 23, 2015

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