We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01975350
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 4, 2013
Last Update Posted : November 4, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Ventilator Associated Pneumonia

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.

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
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
Study Start Date : October 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. intensive care unit stay [ Time Frame: From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months ]
  2. hospital stay [ Time Frame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. ventilator-associated pneumonia rate [ Time Frame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01975350     History of Changes
Other Study ID Numbers: 201303119MINB
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: October 2013

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