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

NCT ID: NCT01975350

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-01

Study Completion Date

2017-08-31

Brief Summary

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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

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

Conditions

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Ventilator Associated Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

saline inhalation

saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wang-Huei Sheng, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Center of Infection Control of National University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201303119MINB

Identifier Type: -

Identifier Source: org_study_id

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