Early Antibiotics After Aspiration in ICU Patients

December 16, 2025 updated by: Mark Metersky, UConn Health

Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health, John Dempsey Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antibiotics

5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum.

Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin.
Drug: Ceftriaxone
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
Drug: Amoxicillin clavulanic acid
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
Other Names:
  • Augmentin
Drug: Cefepime
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
Drug: Vancomycin
If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC (area under the curve/minimum inhibitory concentration) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if MRSA swab is negative.
Drug: Levofloxacin
At any point after 24 hours, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg every 24 hours for the remainder of 5 days
No Intervention: Control
No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU-free Days
Time Frame: From admission to 30 days, death, or hospital discharge, whichever occurs first
Number of days not spent in the ICU, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.
From admission to 30 days, death, or hospital discharge, whichever occurs first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free Days
Time Frame: From admission to 30 days, death, or hospital discharge, whichever occurs first
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.
From admission to 30 days, death, or hospital discharge, whichever occurs first
Hospital-free Days
Time Frame: From admission to 30 days, death, or hospital discharge, whichever occurs first
Number of days not spent in the hospital, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.
From admission to 30 days, death, or hospital discharge, whichever occurs first
Antibiotic-free Days
Time Frame: Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first
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.
Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Intubated After Enrollment
Time Frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Yes/no
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Who Underwent Tracheostomy After Enrollment
Time Frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Yes/no
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Who Developed Pneumonia After Enrollment
Time Frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Yes/no, by criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Days Before Developing Pneumonia Criteria
Time Frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
By criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants Prescribed Additional Antibiotics After Enrollment
Time Frame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics.
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Positive Sputum Culture With a Presumed Pathogen
Time Frame: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Yes/no
Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With Any Positive Culture With an Organism Resistant to Prophylactic Antibiotics
Time Frame: Between admission and 30 days, death, or hospital discharge, whichever occurs first
Yes/no
Between admission and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Positive C. Difficile Stool Toxin Assay After Enrollment
Time Frame: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Yes/no
Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Number of Participants With a Temperature >38 Centigrade on Day 3
Time Frame: Day 3 after enrollment
Yes/no
Day 3 after enrollment
Number of Participants With a White Blood Cell Count >11k on Day 3
Time Frame: Day 3 after enrollment
Yes/no
Day 3 after enrollment
Number of Participants With Arterial Oxygen Saturation / Fraction of Inspired Oxygen (S/F) <215 on Day 3
Time Frame: Day 3 after enrollment
Yes/no
Day 3 after enrollment
Number of Participants With Purulent Secretions on Day 3
Time Frame: Day 3 after enrollment
Yes/no
Day 3 after enrollment
30 Day Mortality
Time Frame: 30 days
Death within 30 days from enrollment
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Investigators

  • Study Director: Brandon Oto, UConn Health, Adult Critical Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Actual)

April 12, 2024

Study Completion (Actual)

April 12, 2024

Study Registration Dates

First Submitted

October 2, 2021

First Submitted That Met QC Criteria

October 2, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-004-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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