Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: ceftriaxone
* Device: Endotracheal tube for aspiration of subglottic secretions.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ceftriaxone|nan|
|Device: Endotracheal tube for aspiration of subglottic secretions.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of early-onset ventilator-associated pneumonia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All ICU-acquired infections. |  |  | 
| Duration of antibiotic therapy. |  |  | 
| Third-generation cephalosporin resistance. |  |  | 
| Duration of intubation and ICU-stay. |  |  | 
| ICU-Mortality. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of pneumonia, ceftriaxone, continuous aspiration, subglottic secretions, Mechanical ventilation with Endotracheal intubation., Absence of infection