Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

Pneumonia, Bacterial Clinical Trial

— CRGNB  

Official title:

Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633317
• Other study ID #: NMRPD1K0861
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2023
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial

Intervention

Device:
• A pneumatic nebulizer
Inhaled colistimethate sodium generated by a pneumatic nebulizer
• A vibrating mesh nebulizer
Inhaled colistimethate sodium generated by a vibrating mesh nebulizer

Locations

Country	Name	City	State
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi City
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung University	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ventilator pressure control level	Ventilator pressure control level setting indirectly indicate lung compliance	7-10 days