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Completed

NCT Number: NCT04633317

Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

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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Key information

Conditions

Pneumonia, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chiayi Chang Gung Memorial Hospital, Chiayi City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

A pneumatic nebulizer

Device

Inhaled colistimethate sodium generated by a pneumatic nebulizer

A vibrating mesh nebulizer

Device

Inhaled colistimethate sodium generated by a vibrating mesh nebulizer

Primary outcomes

  1. Clinical pulmonary infection score

    Time frame: 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 outcomes

  1. Ventilator pressure control level

    Time frame: 7-10 days

    Ventilator pressure control level setting indirectly indicate lung compliance

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia

Acronym: CRGNB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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