Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia

Conditions
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Pneumonia, Bacterial

Intervention / Treatment
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* Device: A pneumatic nebulizer
* Device: A vibrating mesh nebulizer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A Regimen<br>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<br>* Inhaled colistimethate sodium generated by a pneumatic nebulizer<br>Device: A vibrating mesh nebulizer<br>* Inhaled colistimethate sodium generated by a vibrating mesh nebulizer<br>|
| No Intervention: Group B Regimen<br>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?
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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 |