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Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia (CRGNB)

Primary Purpose

Pneumonia, Bacterial

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
A pneumatic nebulizer
A vibrating mesh nebulizer
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Bacterial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients received invasive mechanical ventilation >48 hours
  • Diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria

Exclusion Criteria:

  • pregnant or lactating women
  • receiving colistin > 3 days
  • recurrent pneumonia caused by carbapenem resistance gram negative bacteria
  • allergy to colistin or polymyxin B drugs
  • immunocompromised, defined as neutropenia ANC<500 cells/ul
  • HIV positive
  • received chemotherapy with 3 months
  • renal function deficiency (creatinine clearance < 30 ml/min)

Sites / Locations

  • Chiayi Chang Gung Memorial Hospital
  • Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A Regimen

Group B Regimen

Arm Description

Randomized 80 subjects diagnosed with pneumonia of carbapenem-resistant gram negative bacteria will received inhaled colistimethate sodium generated by a pneumatic nebulizer or a vibrating mesh nebulizer every 12 hours for 7-10 days

Randomized 40 subjects diagnosed with pneumonia of carbapenem-resistant gram negative bacteria will received inhaled colistimethate sodium intravenous every 12 hours for 7-10 days

Outcomes

Primary Outcome Measures

Clinical pulmonary infection score
The clinical pulmonary infection score calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation impairment

Secondary Outcome Measures

Ventilator pressure control level
Ventilator pressure control level setting indirectly indicate lung compliance

Full Information

First Posted
November 14, 2020
Last Updated
May 31, 2023
Sponsor
Chang Gung University
Collaborators
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04633317
Brief Title
Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia
Acronym
CRGNB
Official Title
Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University
Collaborators
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia. We hypothesize that adjunct aerosolized colistin, which achieve high drug concentrations in the airway, would more effectively treat the penumbra.
Detailed Description
To treat respiratory infection of patients with mechanical ventilation, greater systemic antibiotic dose is required through the patient's venous injection. In this trial, patients with arbapenem-resistant gram negative bacteria pneumonia (CRGNB)were assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol. Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between standard care and study drug for their effects on bacteria eradiation, incidence of nephrotoxicity, and oxygenation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A Regimen
Arm Type
Experimental
Arm Description
Randomized 80 subjects diagnosed with pneumonia of carbapenem-resistant gram negative bacteria will received inhaled colistimethate sodium generated by a pneumatic nebulizer or a vibrating mesh nebulizer every 12 hours for 7-10 days
Arm Title
Group B Regimen
Arm Type
No Intervention
Arm Description
Randomized 40 subjects diagnosed with pneumonia of carbapenem-resistant gram negative bacteria will received inhaled colistimethate sodium intravenous every 12 hours for 7-10 days
Intervention Type
Device
Intervention Name(s)
A pneumatic nebulizer
Intervention Description
Inhaled colistimethate sodium generated by a pneumatic nebulizer
Intervention Type
Device
Intervention Name(s)
A vibrating mesh nebulizer
Intervention Description
Inhaled colistimethate sodium generated by a vibrating mesh nebulizer
Primary Outcome Measure Information:
Title
Clinical pulmonary infection score
Description
The clinical pulmonary infection score calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation impairment
Time Frame
7-10 days
Secondary Outcome Measure Information:
Title
Ventilator pressure control level
Description
Ventilator pressure control level setting indirectly indicate lung compliance
Time Frame
7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients received invasive mechanical ventilation >48 hours Diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria Exclusion Criteria: pregnant or lactating women receiving colistin > 3 days recurrent pneumonia caused by carbapenem resistance gram negative bacteria allergy to colistin or polymyxin B drugs immunocompromised, defined as neutropenia ANC<500 cells/ul HIV positive received chemotherapy with 3 months renal function deficiency (creatinine clearance < 30 ml/min)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Ling Lin, MS
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Chiayi City
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

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Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

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