Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

NCT ID: NCT00374959

Last Updated: 2006-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2003-10-31

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.

Conditions

Pneumonia

Keywords

Prevention of pneumonia; ceftriaxone; continuous aspiration; subglottic secretions; Mechanical ventilation with Endotracheal intubation.; Absence of infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

ceftriaxone

Intervention Type: DRUG

Endotracheal tube for aspiration of subglottic secretions.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Hospital Universitario Principe de Asturias

OTHER

Sponsor Role: lead

Principal Investigators

Miguel Sanchez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Principe de Asturias

Locations

Francisco Alvarez Lerma

Barcelona, Barcelona, Spain

Miguel Sanchez Garcia

Alcalá de Henares, Madrid, Spain

Enrique Cerda Cerda

Getafe, Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 8738198 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9731025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7810935 (View on PubMed)

Other Identifiers

TABASCO

Identifier Type: -

Identifier Source: org_study_id