Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

This study has been completed.

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by:

Hospital Universitario Principe de Asturias

ClinicalTrials.gov Identifier:

NCT00374959

First received: September 11, 2006

Last updated: September 25, 2006

Last verified: September 2006

History of Changes

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 4

Study Type:	Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Ceftriaxone Ceftriaxone sodium

U.S. FDA Resources

Further study details as provided by Hospital Universitario 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
Miguel Sanchez Garcia
Alcala de Henares, Madrid, Spain, 28805
Enrique Cerda Cerda
Getafe, Madrid, Spain, 28905
Francisco Alvarez Lerma
Barcelona, Spain, 08003

Sponsors and Collaborators

Hospital Universitario Principe de Asturias

Hoffmann-La Roche

Investigators

Principal Investigator:

Miguel Sanchez, MD, PhD

Hospital Universitario 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.

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

Keywords provided by Hospital Universitario Principe de Asturias:

Prevention of pneumonia
ceftriaxone
continuous aspiration

subglottic secretions
Mechanical ventilation with Endotracheal intubation.
Absence of infection

Additional relevant MeSH terms:

Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection

Ventilator-Induced Lung Injury
Lung Injury
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

To Top