Clinical trial NCT01925066: Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia, Staphylococcal
Methicillin-Resistant Staphylococcus Aureus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2013-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: clinical cure rate
timeFrame: within the first 30 days after treatment
Secondary outcomes:
measure: the peak level of serum vancomycin level
timeFrame: on 3rd and 5th days after treatment
Other outcomes:
measure: microbiological response
timeFrame: within the first 30 days after treatment
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Joon Yim, MD
role: STUDY_DIRECTOR
References:
citation: Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
citation: Cho JY, Kim HS, Yang HJ, Lee YJ, Park JS, Yoon HI, Kim HB, Yim JJ, Lee JH, Lee CT, Cho YJ. Pilot Study of Aerosolised Plus Intravenous Vancomycin in Mechanically Ventilated Patients with Methicillin-Resistant Staphylococcus Aureus Pneumonia. J Clin Med. 2020 Feb 9;9(2):476. doi: 10.3390/jcm9020476.