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

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.

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

Conditions
-----------------
Ventilator Associated Pneumonia

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colistimethate sodium inhalation<br>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<br>saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colistimethate sodium inhalation