Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier:
NCT00374959
First received: September 11, 2006
Last updated: September 25, 2006
Last verified: September 2006

September 11, 2006
September 25, 2006
October 2000
Not Provided
Cumulative incidence of early-onset ventilator-associated pneumonia
Same as current
Complete list of historical versions of study NCT00374959 on ClinicalTrials.gov Archive Site
  • All ICU-acquired infections.
  • Duration of antibiotic therapy.
  • Third-generation cephalosporin resistance.
  • Duration of intubation and ICU-stay.
  • ICU-Mortality.
Same as current
Not Provided
Not Provided
 
Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration
The Prevention of Primary Endogenous Ventilator-Associated Pneumonia: A Multicenter Randomized Trial Comparing Continuous Aspiration of Subglottic Content and a 3-Day Course of Ceftriaxone.

The primary purpose of the trial is to compare the efficacy and safety of two measures which claim to prevent early-onset ventilator-associated pneumonia.

Background: In a previous double-blind, placebo-controlled, randomized trial we found that a 3-day-course of ceftriaxone significantly reduced the incidence of early-onset ventilator-associated pneumonia (EOP). Continuous aspiration of secretions accumulating in the subglottic space above the cuff of the endotracheal tube has also been shown to prevent EOP.

Objective: To compare the effect of both preventive measures on the incidence of EOP.

Design: Randomized, multicenter.

Setting: Three general intensive care units at university hospitals in Spain. Patients: Patients without signs of infection and no concomitant systemic antibiotics were included if expected to require endotracheal intubation exceeding 2 days.

Intervention: All patients were intubated with an endotracheal tube equipped with a port for aspiration of subglottic secretions and subsequently randomized to receive a three day course of 2 gram/day iv ceftriaxone without aspiration of subglottic secretions or continuous aspiration of subglottic secretions.

Measurements: All ICU-acquired infections, antibiotic therapy, colonization and infection with 3rd-generation cephalosporin-resistant microorganisms, duration of intubation and ICU-stay and-mortality.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pneumonia
  • Drug: ceftriaxone
  • Device: Endotracheal tube for aspiration of subglottic secretions.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2003
Not Provided

Inclusion Criteria:

  • Endotracheal intubation with endotracheal tube equipped with port for aspirations of subglottic contents and expected to exceed 48 hors.
  • Absence of infection.
  • 18 years or older.
  • Informed Consent.

Exclusion Criteria:

  • Endotracheal intubation prior to admission to hospital.
  • Allergic to beta-lactam antibiotics.
  • Formal indication for systemic antibiotic therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00374959
TABASCO
Not Provided
Not Provided
Hospital Universitario Principe de Asturias
Hoffmann-La Roche
Principal Investigator: Miguel Sanchez, MD, PhD Hospital Universitario Principe de Asturias
Hospital Universitario Principe de Asturias
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP