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

Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria

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

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in medical intensive care unit with ventilator use

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

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	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wang-Huei Sheng, M.D. Ph.D, Center of Infection Control of National University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 4, 2016
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 3, 2013

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Colistimethate sodium inhalation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Respiratory Aspiration; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 201303119MINB