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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 11, 2006
Last Updated: September 25, 2006
Health Authority: Spain: Ministry of Health

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
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014