Ventilator Associated Pneumonia
Conditions
Keywords
Colistimethate sodium inhalation
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.
Interventions
None listed
Sponsors
National Taiwan University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical cure rate | 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
| Measure | Time frame |
|---|---|
| hospital stay | From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months |
| all cause mortality | From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days |
| 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 |
| ventilator-associated pneumonia rate | 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 |
Countries
Taiwan
Outcome results
None listed