Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia (CRGNB)

Chang Gung University

Status: Completed

Conditions: Pneumonia, Bacterial

Treatments: Device: A vibrating mesh nebulizer; Device: A pneumatic nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT04633317

NMRPD1K0861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group A Regimen

Experimental group

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

Treatment:

Device: A pneumatic nebulizer

Device: A vibrating mesh nebulizer

Group B Regimen

No Intervention group

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