Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia (CRGNB)

Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Bacterial
• Intervention / Treatment: Device: A pneumatic nebulizer; Device: A vibrating mesh nebulizer

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui-Ling Lin, MS; Phone Number: 5228 +886-32118800; Email: huiling@mail.cgu.eud.tw

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Chiayi Chang Gung Memorial Hospital
  • Taoyuan, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A Regimen; 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	Device: A pneumatic nebulizer; Inhaled colistimethate sodium generated by a pneumatic nebulizer; Device: A vibrating mesh nebulizer; Inhaled colistimethate sodium generated by a vibrating mesh nebulizer
No Intervention: Group B Regimen; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator pressure control level	Ventilator pressure control level setting indirectly indicate lung compliance	7-10 days

Collaborators and Investigators

• Sponsor: Chang Gung University
• Collaborators: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Hui-Ling Lin, MS, Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial
• Other Study ID Numbers: NMRPD1K0861

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No