Early Antibiotics After Aspiration in ICU Patients
Phase 4
Terminated
- Conditions
- AspirationAspiration Pneumonia
- Interventions
- Registration Number
- NCT05079620
- Lead Sponsor
- UConn Health
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antibiotics Ceftriaxone 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. Antibiotics Amoxicillin clavulanic acid 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. Antibiotics Vancomycin 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. Antibiotics Cefepime 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. Antibiotics Levofloxacin 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.
- Primary Outcome Measures
Name Time Method ICU-free days From admission to 30 days, death, or hospital discharge, whichever occurs first
- Secondary Outcome Measures
Name Time Method White blood cell count >11k on day 3 Day 3 after enrollment Yes/no
Ventilator-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 Additional antibiotics prescribed Between admission to 30 days, death, or hospital discharge, whichever occurs first Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics.
Positive C. Difficile stool toxin assay after enrollment Between enrollment and 30 days, death, or hospital discharge, whichever occurs first Yes/no
Arterial oxygen saturation / Fraction of inspired oxygen (S/F) <215 on day 3 Day 3 after enrollment Yes/no
Purulent secretions Day 3 after enrollment Yes/no
Days before developing pneumonia criteria 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
Temperature >38 centigrade on day 3 Day 3 after enrollment Yes/no
Hospital-free days From admission to 30 days, death, or hospital discharge, whichever occurs first Intubated after enrollment Between admission to 30 days, death, or hospital discharge, whichever occurs first Yes/no
Tracheostomy after enrollment Between admission to 30 days, death, or hospital discharge, whichever occurs first Yes/no
Developed pneumonia after enrollment 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
Positive sputum culture with presumed pathogen Between enrollment and 30 days, death, or hospital discharge, whichever occurs first Yes/no
Any positive culture with organism resistant to prophylactic antibiotics Between admission and 30 days, death, or hospital discharge, whichever occurs first Yes/no
Trial Locations
- Locations (1)
UConn Health, John Dempsey Hospital
🇺🇸Farmington, Connecticut, United States