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Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
ceftriaxone
Endotracheal tube for aspiration of subglottic secretions.
Sponsored by
Hospital Universitario Principe de Asturias
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Prevention of pneumonia, ceftriaxone, continuous aspiration, subglottic secretions, Mechanical ventilation with Endotracheal intubation., Absence of infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Miguel Sanchez Garcia
  • Enrique Cerda Cerda
  • Francisco Alvarez Lerma

Outcomes

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.

Full Information

First Posted
September 11, 2006
Last Updated
September 25, 2006
Sponsor
Hospital Universitario Principe de Asturias
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00374959
Brief Title
Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Principe de Asturias
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Prevention of pneumonia, ceftriaxone, continuous aspiration, subglottic secretions, Mechanical ventilation with Endotracheal intubation., Absence of infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Intervention Type
Device
Intervention Name(s)
Endotracheal tube for aspiration of subglottic secretions.
Primary Outcome Measure Information:
Title
Cumulative incidence of early-onset ventilator-associated pneumonia
Secondary Outcome Measure Information:
Title
All ICU-acquired infections.
Title
Duration of antibiotic therapy.
Title
Third-generation cephalosporin resistance.
Title
Duration of intubation and ICU-stay.
Title
ICU-Mortality.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Sanchez, MD, PhD
Organizational Affiliation
Hospital Universitario Principe de Asturias
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miguel Sanchez Garcia
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Enrique Cerda Cerda
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Francisco Alvarez Lerma
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
8738198
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. doi: 10.1016/s0195-6701(96)90025-0. No abstract available.
Results Reference
background
PubMed Identifier
9731025
Citation
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.
Results Reference
background
PubMed Identifier
7810935
Citation
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.
Results Reference
background

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Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

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