Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration
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|ClinicalTrials.gov Identifier: NCT00374959|
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : September 26, 2006
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: ceftriaxone Device: Endotracheal tube for aspiration of subglottic secretions.||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2000|
|Estimated Study Completion Date :||October 2003|
- Cumulative incidence of early-onset ventilator-associated pneumonia
- All ICU-acquired infections.
- Duration of antibiotic therapy.
- Third-generation cephalosporin resistance.
- Duration of intubation and ICU-stay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374959
|Miguel Sanchez Garcia|
|Alcala de Henares, Madrid, Spain, 28805|
|Enrique Cerda Cerda|
|Getafe, Madrid, Spain, 28905|
|Francisco Alvarez Lerma|
|Barcelona, Spain, 08003|
|Principal Investigator:||Miguel Sanchez, MD, PhD||Hospital Universitario Principe de Asturias|