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

NCT ID: NCT01925066

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia, Staphylococcal Methicillin-Resistant Staphylococcus Aureus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerosolized Vancomycin

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

Interventions

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Vancomycin

Intervention Type DRUG

Other Intervention Names

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250mg bid, Inhalation for 5-7 days

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae-Joon Yim, MD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 2702835 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32050447 (View on PubMed)

Related Links

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http://linus.nci.nih.gov/brb/samplesize/otsd.html

Optimal Two-Stage Designs For Phase II Clinical Trials

Other Identifiers

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B-1206-156-004

Identifier Type: -

Identifier Source: org_study_id

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