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

Ventilator Associated Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01975350
• Other study ID #: 201303119MINB
• Status: Terminated
• Start date: October 1, 2013
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: August 31, 2017
• Est. primary completion date: February 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Aspiration
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intensive care unit stay		From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
Secondary	hospital stay		From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
Secondary	all cause mortality		From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
Secondary	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
Secondary	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
Secondary	ventilator-associated pneumonia rate		From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months