Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- ICU-free Days
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Ceftriaxone (Drug)
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.
Intervention: Amoxicillin clavulanic acid (Drug)
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.
Intervention: Cefepime (Drug)
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.
Intervention: Vancomycin (Drug)
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.
Intervention: Levofloxacin (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Ventilator-free Days(From admission to 30 days, death, or hospital discharge, whichever occurs first)
- Hospital-free Days(From admission to 30 days, death, or hospital discharge, whichever occurs first)
- Antibiotic-free Days(Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first)
- Number of Participants Intubated After Enrollment(Between admission to 30 days, death, or hospital discharge, whichever occurs first)
- Number of Participants Who Underwent Tracheostomy After Enrollment(Between admission to 30 days, death, or hospital discharge, whichever occurs first)
- Number of Participants Who Developed Pneumonia After Enrollment(Between admission to 30 days, death, or hospital discharge, whichever occurs first)
- Days Before Developing Pneumonia Criteria(Between admission to 30 days, death, or hospital discharge, whichever occurs first)
- Number of Participants Prescribed Additional Antibiotics After Enrollment(Between admission to 30 days, death, or hospital discharge, whichever occurs first)
- Number of Participants With a Positive Sputum Culture With a Presumed Pathogen(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(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(Between enrollment and 30 days, death, or hospital discharge, whichever occurs first)
- Number of Participants With a Temperature >38 Centigrade on Day 3(Day 3 after enrollment)
- Number of Participants With a White Blood Cell Count >11k on Day 3(Day 3 after enrollment)
- Number of Participants With Arterial Oxygen Saturation / Fraction of Inspired Oxygen (S/F) <215 on Day 3(Day 3 after enrollment)
- Number of Participants With Purulent Secretions on Day 3(Day 3 after enrollment)
- 30 Day Mortality(30 days)
Investigators
Mark Metersky
Chief, Division of Pulmonary, Critical Care and Sleep Medicine
UConn Health