Clinical trial NCT05079620: Early Antibiotics After Aspiration in ICU Patients
Official title: Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aspiration
Aspiration Pneumonia
Keywords: ventilator associated pneumonia
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: ICU-free days
timeFrame: From admission to 30 days, death, or hospital discharge, whichever occurs first
Secondary outcomes:
measure: Ventilator-free days
timeFrame: From admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Hospital-free days
timeFrame: From admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Antibiotic-free days
timeFrame: Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Intubated after enrollment
timeFrame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Tracheostomy after enrollment
timeFrame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Developed pneumonia after enrollment
timeFrame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Days before developing pneumonia criteria
timeFrame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Additional antibiotics prescribed
timeFrame: Between admission to 30 days, death, or hospital discharge, whichever occurs first
measure: Positive sputum culture with presumed pathogen
timeFrame: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
measure: Any positive culture with organism resistant to prophylactic antibiotics
timeFrame: Between admission and 30 days, death, or hospital discharge, whichever occurs first
measure: Positive C. Difficile stool toxin assay after enrollment
timeFrame: Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
measure: Temperature >38 centigrade on day 3
timeFrame: Day 3 after enrollment
measure: White blood cell count >11k on day 3
timeFrame: Day 3 after enrollment
measure: Arterial oxygen saturation / Fraction of inspired oxygen (S/F) <215 on day 3
timeFrame: Day 3 after enrollment
measure: Purulent secretions
timeFrame: Day 3 after enrollment
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health, John Dempsey Hospital
state: Connecticut
Study officials:
affiliation: UConn Health, Adult Critical Care
name: Brandon Oto
role: STUDY_DIRECTOR
References:
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