NCT00122057

Brief Summary

The aim of this study is to determine whether antibiotic treatment could reduce mechanical ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration 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

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 1, 2011

Status Verified

September 1, 2006

Enrollment Period

1.9 years

First QC Date

July 14, 2005

Last Update Submit

May 31, 2011

Conditions

Respiratory Tract DiseasesNosocomial Infections

Keywords

ventilator-associated tracheobronchitisnosocomial tracheobronchitis

Outcome Measures

Primary Outcomes (1)

  • duration of mechanical ventilation

Secondary Outcomes (3)

  • length of intensive care unit (ICU) stay

  • mortality rate

  • ventilator-associated pneumonia rate

Interventions

antibiotic treatmentDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation

You may not qualify if:

  • Immunodepressed patients
  • Patients with tracheostomy at ICU admission
  • Patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

12 ICUs in north of France

Lille, France

Location

Related Publications (1)

  • Nseir S, Favory R, Jozefowicz E, Decamps F, Dewavrin F, Brunin G, Di Pompeo C, Mathieu D, Durocher A; VAT Study Group. Antimicrobial treatment for ventilator-associated tracheobronchitis: a randomized, controlled, multicenter study. Crit Care. 2008;12(3):R62. doi: 10.1186/cc6890. Epub 2008 May 2.

    PMID: 18454864DERIVED

MeSH Terms

Conditions

Respiratory Tract DiseasesCross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saad Nseir, MD

    University Hospital of Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2005

First Posted

July 21, 2005

Study Start

June 1, 2005

Primary Completion

May 1, 2007

Study Completion

June 1, 2007

Last Updated

June 1, 2011

Record last verified: 2006-09

Locations

FR(1)