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Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374959
First Posted: September 12, 2006
Last Update Posted: September 26, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
Hospital Universitario Principe de Asturias
  Purpose
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.

Condition Intervention Phase
Pneumonia Drug: ceftriaxone Device: Endotracheal tube for aspiration of subglottic secretions. Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Principe de Asturias:

Primary Outcome Measures:
  • Cumulative incidence of early-onset ventilator-associated pneumonia

Secondary Outcome Measures:
  • All ICU-acquired infections.
  • Duration of antibiotic therapy.
  • Third-generation cephalosporin resistance.
  • Duration of intubation and ICU-stay.
  • ICU-Mortality.

Estimated Enrollment: 80
Study Start Date: October 2000
Estimated Study Completion Date: October 2003
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374959


Locations
Spain
Miguel Sanchez Garcia
Alcala de Henares, Madrid, Spain, 28805
Enrique Cerda Cerda
Getafe, Madrid, Spain, 28905
Francisco Alvarez Lerma
Barcelona, Spain, 08003
Sponsors and Collaborators
Hospital Universitario Principe de Asturias
Hoffmann-La Roche
Investigators
Principal Investigator: Miguel Sanchez, MD, PhD Hospital Universitario Principe de Asturias
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00374959     History of Changes
Other Study ID Numbers: TABASCO
First Submitted: September 11, 2006
First Posted: September 12, 2006
Last Update Posted: September 26, 2006
Last Verified: September 2006

Keywords provided by Hospital Universitario Principe de Asturias:
Prevention of pneumonia
ceftriaxone
continuous aspiration
subglottic secretions
Mechanical ventilation with Endotracheal intubation.
Absence of infection

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents