Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

Not Applicable

Completed

• Conditions: Pneumonia, Bacterial
• Interventions: Device: A pneumatic nebulizer; Device: A vibrating mesh nebulizer

• Registration Number: NCT04633317
• Lead Sponsor: Chang Gung University

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.

Study Timeline

• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-18
• Study Start: 2020-12-15
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A Regimen	A vibrating mesh nebulizer	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
Group A Regimen	A pneumatic nebulizer	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

Primary Outcome Measures

Name	Time	Method
Clinical pulmonary infection score	7-10 days	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

Name	Time	Method
Ventilator pressure control level	7-10 days	Ventilator pressure control level setting indirectly indicate lung compliance

Trial Locations

Locations (2)

Chiayi Chang Gung Memorial Hospital; 🇨🇳 Chiayi City, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan