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

NCT01975350 | Terminated DMC

• 1 other identifier: 201303119MINB
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Colistimethate sodium inhalation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in medical intensive care unit with ventilator use

You may qualify if:

• age ≥ 20 years old
• medical ICU patients with invasive ventilator use ≥ 48 hours
• multidrug resistant Gram-negative bacteria obtained from lower respiratory tract

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wang-Huei Sheng, M.D. Ph.D

  Center of Infection Control of National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 4, 2013
• Study Start: October 1, 2013
• Primary Completion: February 4, 2016
• Study Completion: August 31, 2017
• Last Updated: March 16, 2021

Record last verified: 2013-10

Locations

TW (1)