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Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

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ClinicalTrials.gov Identifier: NCT00374959
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : September 26, 2006
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hospital Universitario Principe de Asturias

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumonia Drug: ceftriaxone Device: Endotracheal tube for aspiration of subglottic secretions. Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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.
Study Start Date : October 2000
Estimated Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. All ICU-acquired infections.
  2. Duration of antibiotic therapy.
  3. Third-generation cephalosporin resistance.
  4. Duration of intubation and ICU-stay.
  5. ICU-Mortality.


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.

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