Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

Pneumonia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374959
• Other study ID #: TABASCO
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2006
• Last updated: September 25, 2006
• Start date: October 2000
• Est. completion date: October 2003

Study information

• Verified date: September 2006
• Source: Hospital Universitario Principe de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Drug:
• ceftriaxone

Device:
• Endotracheal tube for aspiration of subglottic secretions.

Locations

Country	Name	City	State
Spain	Miguel Sanchez Garcia	Alcala de Henares	Madrid
Spain	Francisco Alvarez Lerma	Barcelona
Spain	Enrique Cerda Cerda	Getafe	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Principe de Asturias	Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Sánchez García M, Cambronero Galache JA, López Diaz J, Cerdá Cerdá E, Rubio Blasco J, Gómez Aguinaga MA, Núnez Reiz A, Rogero Marín S, Onoro Canaveral JJ, Sacristán 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. — View Citation

Vallés J, Artigas A, Rello J, Bonsoms N, Fontanals D, Blanch L, Fernández 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of early-onset ventilator-associated pneumonia
Secondary	All ICU-acquired infections.
Secondary	Duration of antibiotic therapy.
Secondary	Third-generation cephalosporin resistance.
Secondary	Duration of intubation and ICU-stay.
Secondary	ICU-Mortality.