NCT01975350TerminatedNot Applicable
Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria
National Taiwan University Hospital1 site in 1 country49 target enrollmentStarted: October 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- clinical cure rate
Study Overview
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.
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
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥ 20 years old
- •medical ICU patients with invasive ventilator use ≥ 48 hours
- •multidrug resistant Gram-negative bacteria obtained from lower respiratory tract
Exclusion Criteria
- •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
- •patients who refuse to receive any inhaled therapy
Outcomes
Primary Outcomes
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 Outcomes
- all cause mortality(From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days)
- ventilator-associated pneumonia rate(From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months)
- intensive care unit stay(From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months)
- microbiologic eradication in colonization patients(From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days)
- hospital stay(From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months)
- ventilator-associated pneumonia-related mortality(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)
Investigators
Study Sites (1)
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