NCT00374959

Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: Hospital Universitario Principe de Asturias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	ceftriaxone
DEVICE	Endotracheal tube for aspiration of subglottic secretions.

Timeline

• Start date: 2000-10-01
• Completion: 2003-10-01
• First posted: 2006-09-12
• Last updated: 2006-09-26

Locations

3 sites across 1 country: Spain