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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01975350
Other study ID # 201303119MINB
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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