Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
- 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 Outcome Measures
- intensive care unit stay [From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months]
- 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]
- 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]
- 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]
Eligibility Criteria
Criteria
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:
-
pregnancy
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201303119MINB