Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-07-31

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.

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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.

Conditions

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Pneumonia, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

A pneumatic nebulizer

Intervention Type DEVICE

Inhaled colistimethate sodium generated by a pneumatic nebulizer

A vibrating mesh nebulizer

Intervention Type DEVICE

Inhaled colistimethate sodium generated by a vibrating mesh nebulizer

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A pneumatic nebulizer

Inhaled colistimethate sodium generated by a pneumatic nebulizer

Intervention Type DEVICE

A vibrating mesh nebulizer

Inhaled colistimethate sodium generated by a vibrating mesh nebulizer

Intervention Type DEVICE

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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No