Early Antibiotics After Aspiration in ICU Patients

Phase 4TerminatedNCT05079620

UConn Health5 enrolled

Overview

The purpose of this study is to evaluate the use of early antibiotics in ICU patients who appear to have aspirated, to help determine whether this improves outcomes by reducing the later incidence of pneumonia and other negative consequences.

ICU patients with signs of aspiration on imaging and a clinical history supportive of aspiration, but with no clear signs of infectious pneumonia, will be randomized to receive either 5 days of empiric antibiotics or supportive care only. They will be followed for 30 days with a primary outcome of ICU length-of-stay and various secondary outcomes including mortality, ventilator days, and antibiotic days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Aspiration Aspiration Pneumonia

Interventions

CeftriaxoneDRUG

If there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days

Amoxicillin clavulanic acidDRUG

At any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days

CefepimeDRUG

If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Admitted to the ICU within the last 24 hours, or with a witnessed aspiration event in the last 24 hours while in the ICU * Radiographic findings on chest x-ray or CT deemed by the treating ICU team to be consistent with aspiration (e.g. dependent infiltrates or intraluminal airway debris) * Clinical history consistent with possible aspiration (e.g. cardiac arrest, found unconscious, or with a witnessed aspiration event). Exclusion Criteria: * Already received 3 or more doses of any antibiotic since hospital presentation, unless the last dose was greater than 1 week before enrollment * Requires antibiotic therapy for the treatment of other infections * Patient "comfort measures only" at time of screening * Currently participating in other trials using investigational drugs or interventions * Currently pregnant * Currently a prisoner * The consenting party (patient or their legally authorized representative) is unable to understand or read English at a fifth-grade level. * 2 or more of the following are present at the time of screening: * White blood cell count: ≥ 11.0 * Temperature ≥ 38.0C (100.4F) * Purulent secretions * S/F (pulse oximetry saturation to FiO2) ratio ≤ 215

Locations (1)

UConn Health, John Dempsey Hospital

Farmington, Connecticut, United States

Outcomes

Primary Outcomes

ICU-free Days

Number of days not spent in the ICU, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.

Time frame: From admission to 30 days, death, or hospital discharge, whichever occurs first

Secondary Outcomes

Ventilator-free Days

Number of days without any mechanical ventilation, between date of admission and 30 days afterwards. Death, discharge, or mechanical ventilation can both reduce this measure.

Time frame: From admission to 30 days, death, or hospital discharge, whichever occurs first

Hospital-free Days

Number of days not spent in the hospital, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.

Time frame: From admission to 30 days, death, or hospital discharge, whichever occurs first

Antibiotic-free Days

Number of days without any antibiotics administered, between date of admission and 30 days afterwards. Death, discharge, or antibiotic use can all reduce this measure.

Time frame: Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first

Number of Participants Intubated After Enrollment

Yes/no

Time frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first

Number of Participants Who Underwent Tracheostomy After Enrollment

Yes/no

Time frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first

Number of Participants Who Developed Pneumonia After Enrollment

Data from ClinicalTrials.gov

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