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.
Device: Endotracheal tube for aspiration of subglottic secretions.
|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.|
- Cumulative incidence of early-onset ventilator-associated pneumonia
- All ICU-acquired infections.
- Duration of antibiotic therapy.
- Third-generation cephalosporin resistance.
- Duration of intubation and ICU-stay.
|Study Start Date:||October 2000|
|Estimated Study Completion Date:||October 2003|
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.
|Miguel Sanchez Garcia|
|Alcala de Henares, Madrid, Spain, 28805|
|Enrique Cerda Cerda|
|Getafe, Madrid, Spain, 28905|
|Francisco Alvarez Lerma|
|Barcelona, Spain, 08003|
|Principal Investigator:||Miguel Sanchez, MD, PhD||Hospital Universitario Principe de Asturias|