Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

NCT00374959 | Completed Phase 4

• 1 other identifier: TABASCO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of early-onset ventilator-associated pneumonia

Secondary Outcomes (5)

• All ICU-acquired infections.

• Duration of antibiotic therapy.

• Third-generation cephalosporin resistance.

• Duration of intubation and ICU-stay.

• ICU-Mortality.

Interventions

ceftriaxone DRUG

Endotracheal tube for aspiration of subglottic secretions. DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endotracheal intubation with endotracheal tube equipped with port for aspirations of subglottic contents and expected to exceed 48 hors.
• Absence of infection.
• years or older.
• Informed Consent.

You may not qualify if:

• Endotracheal intubation prior to admission to hospital.
• Allergic to beta-lactam antibiotics.
• Formal indication for systemic antibiotic therapy.

Sponsors & Collaborators

• Hospital Universitario Principe de Asturias: lead
• Hoffmann-La Roche: collaborator

Study Sites (3)

Francisco Alvarez Lerma

Barcelona, Barcelona, 08003, Spain

Location

Miguel Sanchez Garcia

Alcalá de Henares, Madrid, 28805, Spain

Location

Enrique Cerda Cerda

Getafe, Madrid, 28905, Spain

Location

Related Publications (3)

• 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.

  PMID: 8738198 BACKGROUND

• 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.

  PMID: 9731025 BACKGROUND

• 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.

  PMID: 7810935 BACKGROUND

MeSH Terms

Conditions

Pneumonia

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Miguel Sanchez, MD, PhD

  Hospital Universitario Principe de Asturias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 12, 2006
• Study Start: October 1, 2000
• Study Completion: October 1, 2003
• Last Updated: September 26, 2006

Record last verified: 2006-09

Locations

ES (3)