NCT Number: NCT00374959
Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Francisco Alvarez Lerma, Barcelona, Spain
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Endotracheal tube for aspiration of subglottic secretions.
DevicePrimary outcomes
-
Cumulative incidence of early-onset ventilator-associated pneumonia
Secondary outcomes
-
All ICU-acquired infections.
-
Duration of antibiotic therapy.
-
Third-generation cephalosporin resistance.
-
Duration of intubation and ICU-stay.
-
ICU-Mortality.
Sponsors and collaborators
Lead sponsor
Hospital Universitario Principe de Asturias
Other
Collaborators
- Hoffmann-La Roche
Registry information
Official study 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.
Important dates
- Study start
- 2000
- Study completion
- 2003
- First posted
- Sep 12, 2006
- Registry last updated
- Sep 26, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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