Trial record 11 of 936 for:    ventilators

Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia

This study is currently recruiting participants.
Verified October 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01975350
First received: October 22, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.


Condition
Ventilator Associated Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • clinical cure rate [ Time Frame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days ] [ Designated as safety issue: No ]
    including clinical improvement and microbiological outcome(eradication of the pathogen as no growth of the pathogen in the final culture of specimens during the entire hospitalization)


Secondary Outcome Measures:
  • intensive care unit stay [ Time Frame: From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months ] [ Designated as safety issue: No ]
  • hospital stay [ Time Frame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months ] [ Designated as safety issue: No ]
  • all cause mortality [ Time Frame: From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days ] [ Designated as safety issue: No ]
  • ventilator-associated pneumonia-related mortality [ Time Frame: Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days ] [ Designated as safety issue: No ]
  • microbiologic eradication in colonization patients [ Time Frame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days ] [ Designated as safety issue: No ]
  • ventilator-associated pneumonia rate [ Time Frame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Colistimethate sodium inhalation

Colistimethate sodium inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.

Additional intravenous colistimethate sodium for patients with ventilator-associated pneumonia

saline inhalation
saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.

Detailed Description:

Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients in medical intensive care unit with ventilator use

Criteria

Inclusion Criteria:

  1. age ≥ 20 years old
  2. medical ICU patients with invasive ventilator use ≥ 48 hours
  3. multidrug resistant Gram-negative bacteria obtained from lower respiratory tract

Exclusion Criteria:

  1. pregnancy
  2. concurrent use of other antimicrobial agents active for isolated multidrug resistant Gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam
  3. patients who refuse to receive any inhaled therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01975350

Contacts
Contact: Wang-Huei Sheng, M.D. Ph.D 886-2-23123456 ext 67736 whsheng@ntu.edu.tw; 007363@ntuh.gov.tw
Contact: Ying-Chun Chien, M.D. 886-2-23123456 ext 67736 019466@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Wang-Huei Sheng, M.D. Ph.D    886-2-23123456 ext 67736    whsheng@ntu.edu.tw; 007363@ntuh.gov.tw   
Sub-Investigator: Ying-Chun Chien, M.D.         
Sub-Investigator: Yu-Chung Chuang, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wang-Huei Sheng, M.D. Ph.D Center of Infection Control of National University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01975350     History of Changes
Other Study ID Numbers: 201303119MINB
Study First Received: October 22, 2013
Last Updated: October 28, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Taiwan University Hospital:
Colistimethate sodium inhalation

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Ventilator-Induced Lung Injury
Respiratory Aspiration
Pneumonia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Respiratory Tract Infections
Cross Infection
Infection
Lung Injury
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014