- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374959
Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Barcelona, Spain, 08003
- Francisco Alvarez Lerma
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Madrid
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Alcala de Henares, Madrid, Spain, 28805
- Miguel Sanchez Garcia
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Getafe, Madrid, Spain, 28905
- Enrique Cerda Cerda
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cumulative incidence of early-onset ventilator-associated pneumonia
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Secondary Outcome Measures
Outcome Measure |
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All ICU-acquired infections.
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Duration of antibiotic therapy.
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Third-generation cephalosporin resistance.
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Duration of intubation and ICU-stay.
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ICU-Mortality.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Miguel Sanchez, MD, PhD, Hospital Universitario Príncipe de Asturias
Publications and helpful links
General 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. doi: 10.1016/s0195-6701(96)90025-0. 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. doi: 10.1164/ajrccm.158.3.9712079.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TABASCO
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