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OpenTrials
Completed

NCT Number: NCT00374959

Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Francisco Alvarez Lerma, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ceftriaxone

Drug

Endotracheal tube for aspiration of subglottic secretions.

Device

Primary outcomes

  1. Cumulative incidence of early-onset ventilator-associated pneumonia

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Principe de Asturias

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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.

Important dates

Study start
2000
Study completion
2003
First posted
Sep 12, 2006
Registry last updated
Sep 26, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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