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

Methicillin-Resistant Staphylococcus Aureus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925066
• Other study ID #: B-1206-156-004
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Methicillin-Resistant Staphylococcus Aureus
• Pneumonia
• Pneumonia, Staphylococcal
• Staphylococcal Infections

Intervention

Drug:
• Vancomycin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	microbiological response		within the first 30 days after treatment
Primary	clinical cure rate		within the first 30 days after treatment
Secondary	the peak level of serum vancomycin level		on 3rd and 5th days after treatment

External Links

•   Optimal Two-Stage Designs For Phase II Clinical Trials