Clinical trial NCT01975350: Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventilator Associated Pneumonia
Keywords: Colistimethate sodium inhalation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in medical intensive care unit with ventilator use

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical cure rate
timeFrame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
Secondary outcomes:
measure: intensive care unit stay
timeFrame: From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
measure: hospital stay
timeFrame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
measure: all cause mortality
timeFrame: From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
measure: ventilator-associated pneumonia-related mortality
timeFrame: 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
measure: microbiologic eradication in colonization patients
timeFrame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
measure: ventilator-associated pneumonia rate
timeFrame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Center of Infection Control of National University Hospital
name: Wang-Huei Sheng, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: