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TerminatedNCT01975350Updated Mar 16, 2021

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

An observational study in Ventilator Associated Pneumonia, sponsored by National Taiwan University Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
49
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • Colistimethate sodium inhalation
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 49 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients in medical intensive care unit with ventilator use

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
49 participants (actual)
Patient registry
No

Groups and 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.

06

What researchers measure

Primary outcomes

  1. clinical cure rate

    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)

    Time frame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days

Secondary outcomes

  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

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Study locations

1 site
  • National Taiwan University Hospital
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01975350
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Nov 3, 2013
Start date
Oct 1, 2013
Primary completion
Feb 4, 2016
Completion
Aug 31, 2017
Last update
Mar 16, 2021

Study contacts

Wang-Huei Sheng, M.D. Ph.D
principal investigator · Center of Infection Control of National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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