NCT04208945

Brief Summary

Colistin is used as an elective treatment of infections of multi drug resistant gram negative bacteria. Until now colistin is used in the therapeutic regimen of these infections intravenous or nebulized. There are a plenty of studies about the efficacy of nebulized colistin in the therapy of pseudomonas aeruginosa pneumonia in patients with cystic fibrosis and in the therapy of ventilator associated pneumonia in ICU. On the other hand there are only a few studies about the use of nebulized colistin in the prevention of ventilator associated pneumonia whereas the role of nebulized colistin in the prevention of severe forms of pneumonia such as VAP due to multi drug resistant gram negative bacteria are limited. This double blinded randomized trial aim to investigate the effect of nebulized colistin on the incidence of patients with due to gram negative bacteria in the ICU compared to nebulized normal saline.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

3 active sites

Status
unknown

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 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

November 25, 2019

Last Update Submit

December 19, 2019

Conditions

Pneumonia, Ventilator-associatedGram-Negative Pneumonia

Keywords

Ventilator Associated PneumoniaPneumoniaGram negative bacteriaVentilator Associated Infectioninhaled antibioticscolistin

Outcome Measures

Primary Outcomes (1)

  • The 28th day incidence of gram negative bacterial Ventilator-associated-pneumonia (VAP)

    The 28th day incidence will be estimated as the percentage (%) of patients with at least an episode of gram negative bacterial Ventilator-associated- pneumonia (VAP), from randomization to the 28th day, among patients hospitalised in the intensive care unit. Diagnosis of VAP will be based on clinical criteria and will require microbiological confirmation

    28 days

Secondary Outcomes (2)

  • Colistin resistant bacteria in tracheobronchial aspirate (TBA) or blood

    28 days

  • 28 day mortality

    28 days

Study Arms (2)

Inhaled colistin

EXPERIMENTAL

Inhaled colistin three times daily for 10 days

Drug: Colistin

Standard management

NO INTERVENTION

Interventions

ColistinDRUG

500000 units of inhaled colistin three times daily for 10 days

Also known as: Colistin Methylsuphate
Inhaled colistin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Mechanical ventilation through an endotracheal tube \> 48h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital of Larisa

Larissa, Greece/Thessaly, 41110, Greece

RECRUITING

General Hospital of Volos Thessaly

Volos, Thessaly, 38222, Greece

RECRUITING

Evangelismos University Hospital of Athens

Athens, 10676, Greece

RECRUITING

Related Publications (1)

  • Cocanour CS, Ostrosky-Zeichner L, Peninger M, Garbade D, Tidemann T, Domonoske BD, Li T, Allen SJ, Luther KM. Cost of a ventilator-associated pneumonia in a shock trauma intensive care unit. Surg Infect (Larchmt). 2005 Spring;6(1):65-72. doi: 10.1089/sur.2005.6.65.

    PMID: 15865552RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPneumonia

Interventions

Colistin

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Officials

  • DEMOSTHENES MAKRIS, as prof

    INTENSIVE CARE DEPARTMENT UNIVERSITY HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DEMOSTHENES MAKRIS, Associate Prof

CONTACT

+3022413502008appollon7@hotmail.com

Epameinondas Zakynthinos, Prof

CONTACT

+3022413501280ezakynth@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD in ICU, (Professor and ICU director Zakynthinos Epaminondas)

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 23, 2019

Study Start

December 1, 2019

Primary Completion

April 1, 2021

Study Completion

September 1, 2021

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(3)