NCT04633317

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

November 14, 2020

Last Update Submit

May 31, 2023

Conditions

Pneumonia, Bacterial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ventilator pressure control level

    7-10 days

Study Arms (2)

Group A Regimen

EXPERIMENTAL

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 nebulizerDevice: A vibrating mesh nebulizer

Group B Regimen

NO INTERVENTION

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

Interventions

A pneumatic nebulizerDEVICE

Inhaled colistimethate sodium generated by a pneumatic nebulizer

Group A Regimen
A vibrating mesh nebulizerDEVICE

Inhaled colistimethate sodium generated by a vibrating mesh nebulizer

Group A Regimen

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients received invasive mechanical ventilation \>48 hours
  • Diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chiayi Chang Gung Memorial Hospital

Chiayi City, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (1)

  • Huang CC, Fang TP, Lin CM, Chu CM, Hsiao HL, Liu JF, Li HH, Chiu LC, Kao KC, Kuo CH, Leu SW, Lin HL. Evaluating the Efficacy of Inhaled Colistin via Two Nebulizer Types in Ventilator-Associated Pneumonia: Prospective Randomized Trial. Antibiotics (Basel). 2024 Nov 19;13(11):1099. doi: 10.3390/antibiotics13111099.

    PMID: 39596792DERIVED

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hui-Ling Lin, MS

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 14, 2020

First Posted

November 18, 2020

Study Start

December 15, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations

TW(2)