Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pneumonia	Drug: ceftriaxone Device: Endotracheal tube for aspiration of subglottic secretions.	Phase IV

MedlinePlus related topics:

Pneumonia

Drug Information available for:

Ceftriaxone Ceftriaxone Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Hospital Principe de Asturias:

Primary Outcome Measures:

Cumulative incidence of early-onset ventilator-associated pneumonia

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	October 2000
Estimated Study Completion Date:	October 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374959

Locations


Spain
	Francisco Alvarez Lerma
	Barcelona, Spain, 08003

Spain, Madrid
	Enrique Cerda Cerda
	Getafe, Madrid, Spain, 28905
	Miguel Sanchez Garcia
	Alcala de Henares, Madrid, Spain, 28805

Sponsors and Collaborators

Hospital Principe de Asturias

Hoffmann-La Roche

Investigators


Principal Investigator:	Miguel Sanchez, MD, PhD	Hospital Principe de Asturias

More Information

Publications:

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. Review. No abstract available.

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.

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.

Study ID Numbers:	TABASCO
First Received:	September 11, 2006
Last Updated:	September 25, 2006
ClinicalTrials.gov Identifier:	NCT00374959
Health Authority:	Spain: Ministry of Health

Keywords provided by Hospital Principe de Asturias:

Prevention of pneumonia

ceftriaxone

continuous aspiration

subglottic secretions

Mechanical ventilation with Endotracheal intubation.

Absence of infection

Study placed in the following topic categories:

Respiratory Tract Infections

Respiratory Tract Diseases

Lung Diseases

Ceftriaxone

Pneumonia, Ventilator-Associated

Cross Infection

Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Therapeutic Uses

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008

Sponsors and Collaborators:	Hospital Principe de Asturias Hoffmann-La Roche
Information provided by:	Hospital Principe de Asturias
ClinicalTrials.gov Identifier:	NCT00374959