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Clinical Trials/NCT00374959
NCT00374959
Completed
Phase 4

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.

Hospital Universitario Principe de Asturias3 sites in 1 country80 target enrollmentOctober 2000
ConditionsPneumonia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pneumonia
Sponsor
Hospital Universitario Principe de Asturias
Enrollment
80
Locations
3
Primary Endpoint
Cumulative incidence of early-onset ventilator-associated pneumonia
Status
Completed
Last Updated
19 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2000
End Date
October 2003
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Cumulative incidence of early-onset ventilator-associated pneumonia

Secondary Outcomes

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

Study Sites (3)

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