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Prevention of Pneumonia Comparing Ceftriaxone With Subglottic Aspiration

M

Madrid Health Service

Status and phase

Completed
Phase 4

Conditions

Pneumonia

Treatments

Drug: ceftriaxone
Device: Endotracheal tube for aspiration of subglottic secretions.

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00374959
TABASCO

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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