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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pneumonia
Respiratory Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Pathologic Processes
Cross Infection
Infection
Lung Injury
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014