Aerosolized Vancomycin in Methicillin-Resistant Staphyloc... | NCT01925066

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

NCT01925066

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 23, 2019Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Pneumonia, Staphylococcal
Methicillin-Resistant Staphylococcus Aureus

Interventions

Vancomycin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Aug 15, 2013

First Submission Date that Met QC Criteria

Aug 15, 2013

First Posted Date

Aug 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2019

Last Update Posted Date

Apr 23, 2019Actual

Name	Class
Seoul National University Bundang Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
Aerosolized Vancomycin	Experimental		Drug: Vancomycin

Name	Type	Description	Arm Group Labels	Other Names
Vancomycin	Drug		Aerosolized Vancomycin	250mg bid, Inhalation for 5-7 days

Measure	Description	Time Frame
clinical cure rate		within the first 30 days after treatment

Measure	Description	Time Frame
the peak level of serum vancomycin level		on 3rd and 5th days after treatment

Measure	Description	Time Frame
microbiological response		within the first 30 days after treatment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jae-Joon Yim, MD	Seoul National University Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2702835	Background	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.
32050447	Derived	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.

Type	Date	Date Unknown
Release	Apr 7, 2021
Reset	Apr 30, 2021

ID	Term
D013203	Staphylococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

ID	Term
D014640	Vancomycin
C494814	BID protein, human
D001239	Inhalation

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides