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

NCT01925066 | Completed Phase 2 DMC

• 1 other identifier: B-1206-156-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Staphylococcal; Methicillin-Resistant Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

• clinical cure rate

  within the first 30 days after treatment

Secondary Outcomes (1)

• the peak level of serum vancomycin level

  on 3rd and 5th days after treatment

Other Outcomes (1)

• microbiological response

  within the first 30 days after treatment

Study Arms (1)

Aerosolized Vancomycin

EXPERIMENTAL

Drug: Vancomycin

Interventions

Vancomycin DRUG

Also known as: 250mg bid, Inhalation for 5-7 days

Aerosolized Vancomycin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nosocomial or severe community-acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus
• Must be mechanically ventilated in intensive care unit

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (2)

• 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.

  PMID: 2702835 BACKGROUND

• 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.

  PMID: 32050447 DERIVED

Related Links

• Optimal Two-Stage Designs For Phase II Clinical Trials

MeSH Terms

Conditions

Pneumonia, Staphylococcal

Interventions

Vancomycin; BID protein, human; Inhalation

Condition Hierarchy (Ancestors)

Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Jae-Joon Yim, MD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

KR (1)