Clinical trial NCT00374959: Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Keywords: Prevention of pneumonia
ceftriaxone
continuous aspiration
subglottic secretions
Mechanical ventilation with Endotracheal intubation.
Absence of infection
Lead sponsor: Hospital Universitario Principe de Asturias
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-09-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of early-onset ventilator-associated pneumonia
Secondary outcomes:
measure: All ICU-acquired infections.
measure: Duration of antibiotic therapy.
measure: Third-generation cephalosporin resistance.
measure: Duration of intubation and ICU-stay.
measure: ICU-Mortality.
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Miguel Sanchez Garcia
state: Madrid
city: Getafe
country: Spain
facility: Enrique Cerda Cerda
state: Madrid
city: Barcelona
country: Spain
facility: Francisco Alvarez Lerma
Study officials:
affiliation: Hospital Universitario Principe de Asturias
name: Miguel Sanchez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Saene HK, Damjanovic V, Murray AE, de la Cal MA. How to classify infections in intensive care units--the carrier state, a criterion whose time has come? J Hosp Infect. 1996 May;33(1):1-12. doi: 10.1016/s0195-6701(96)90025-0. No abstract available.
citation: Sanchez Garcia M, Cambronero Galache JA, Lopez Diaz J, Cerda Cerda E, Rubio Blasco J, Gomez Aguinaga MA, Nunez Reiz A, Rogero Marin S, Onoro Canaveral JJ, Sacristan del Castillo JA. Effectiveness and cost of selective decontamination of the digestive tract in critically ill intubated patients. A randomized, double-blind, placebo-controlled, multicenter trial. Am J Respir Crit Care Med. 1998 Sep;158(3):908-16. doi: 10.1164/ajrccm.158.3.9712079.
citation: Valles J, Artigas A, Rello J, Bonsoms N, Fontanals D, Blanch L, Fernandez R, Baigorri F, Mestre J. Continuous aspiration of subglottic secretions in preventing ventilator-associated pneumonia. Ann Intern Med. 1995 Feb 1;122(3):179-86. doi: 10.7326/0003-4819-122-3-199502010-00004.