Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

Phase 4

Completed

• Conditions: Pneumonia

• Registration Number: NCT00374959
• Lead Sponsor: Hospital Universitario Principe de Asturias

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.

Study Timeline

• Study Start: 2000-10
• Study Completion: 2003-10
• Status Verified: 2006-09
• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-12
• Last Update Submitted: 2006-09-25
• Last Update Posted: 2006-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of early-onset ventilator-associated pneumonia

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Miguel Sanchez Garcia; 🇪🇸 Alcala de Henares, Madrid, Spain

Enrique Cerda Cerda; 🇪🇸 Getafe, Madrid, Spain

Francisco Alvarez Lerma; 🇪🇸 Barcelona, Spain