NCT01025921

Brief Summary

We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

3.5 years

First QC Date

December 3, 2009

Last Update Submit

May 31, 2013

Conditions

TracheobronchitisPneumonia

Keywords

Tracheobronchitispneumoniainhaled antibioticscolistinVentilator associated tracheobronchitisVentilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • Incidence of tracheobronchitis and ventilator associated pneumonia

    30 days

Secondary Outcomes (1)

  • Ventilator free days and ICU length of stay

    30 days

Study Arms (2)

Inhaled colistin

PLACEBO COMPARATOR

They will receive inhaled colistin three times daily for 10 days.

Drug: colistin (Tadim)

Inhaled normal saline

PLACEBO COMPARATOR

Inhaled normal saline three times daily for 10 days

Other: inhaled normal saline

Interventions

colistin (Tadim)DRUG

500.000 units of inhaled colistin three times daily for 10 days

Inhaled colistin
inhaled normal salineOTHER

inhalation of 2,5cc Normal Saline via nebulisation

Inhaled normal saline

Eligibility Criteria

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

You may qualify if:

  • All intubated and tracheostomized patients, older than 18 years old with duration of intubation of 48 hours.

You may not qualify if:

  • Purulent sputum within 48 hours from admission
  • Pneumonia within 48 hours of intubation
  • New chest X ray infiltrate
  • Advanced COPD that led to intubation
  • Pregnancy
  • Allergy to colistin
  • Resistance of the bacterial strain to colistin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Larissa

Larissa, 41110, Greece

Location

MeSH Terms

Conditions

PneumoniaPneumonia, Ventilator-Associated

Interventions

Colistin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesHealthcare-Associated PneumoniaCross InfectionIatrogenic 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 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
Professor and ICU Director Zakynthinos Epaminondas

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

GR(1)