Back to resultsEarly Antibiotics After Aspiration in ICU Patients
Primary Purpose
Aspiration, Aspiration Pneumonia
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ceftriaxone
Amoxicillin clavulanic acid
Cefepime
Vancomycin
Levofloxacin
Sponsored by
About this trial
This is an interventional prevention trial for Aspiration focused on measuring ventilator associated pneumonia
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
Sites / Locations
- UConn Health, John Dempsey HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Antibiotics
Control
Arm Description
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.
No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.
Outcomes
Primary Outcome Measures
ICU-free days
Secondary Outcome Measures
Ventilator-free days
Hospital-free days
Antibiotic-free days
Intubated after enrollment
Yes/no
Tracheostomy after enrollment
Yes/no
Developed pneumonia after enrollment
Yes/no, by criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Days before developing pneumonia criteria
By criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Additional antibiotics prescribed
Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics.
Positive sputum culture with presumed pathogen
Yes/no
Any positive culture with organism resistant to prophylactic antibiotics
Yes/no
Positive C. Difficile stool toxin assay after enrollment
Yes/no
Temperature >38 centigrade on day 3
Yes/no
White blood cell count >11k on day 3
Yes/no
Arterial oxygen saturation / Fraction of inspired oxygen (S/F) <215 on day 3
Yes/no
Purulent secretions
Yes/no
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05079620
Brief Title
Early Antibiotics After Aspiration in ICU Patients
Official Title
Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration, Aspiration Pneumonia
Keywords
ventilator associated pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Amoxicillin clavulanic acid
Other Intervention Name(s)
Augmentin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cefepime
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
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
Primary Outcome Measure Information:
Title
ICU-free days
Time Frame
From admission to 30 days, death, or hospital discharge, whichever occurs first
Secondary Outcome Measure Information:
Title
Ventilator-free days
Time Frame
From admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Hospital-free days
Time Frame
From admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Antibiotic-free days
Time Frame
Days with no antibiotics from admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Intubated after enrollment
Description
Yes/no
Time Frame
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Tracheostomy after enrollment
Description
Yes/no
Time Frame
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Developed pneumonia after enrollment
Description
Yes/no, by criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Time Frame
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Days before developing pneumonia criteria
Description
By criteria: 2 or more present simultaneously of temperature >38c, WBC >11k, S/F ratio <215, and purulent secretions
Time Frame
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Additional antibiotics prescribed
Description
Yes/no. Excluding prophylactic antibiotics and excluding perioperative prophylactic antibiotics.
Time Frame
Between admission to 30 days, death, or hospital discharge, whichever occurs first
Title
Positive sputum culture with presumed pathogen
Description
Yes/no
Time Frame
Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Title
Any positive culture with organism resistant to prophylactic antibiotics
Description
Yes/no
Time Frame
Between admission and 30 days, death, or hospital discharge, whichever occurs first
Title
Positive C. Difficile stool toxin assay after enrollment
Description
Yes/no
Time Frame
Between enrollment and 30 days, death, or hospital discharge, whichever occurs first
Title
Temperature >38 centigrade on day 3
Description
Yes/no
Time Frame
Day 3 after enrollment
Title
White blood cell count >11k on day 3
Description
Yes/no
Time Frame
Day 3 after enrollment
Title
Arterial oxygen saturation / Fraction of inspired oxygen (S/F) <215 on day 3
Description
Yes/no
Time Frame
Day 3 after enrollment
Title
Purulent secretions
Description
Yes/no
Time Frame
Day 3 after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Oto, PA-C
Phone
860-679-3107
Email
oto@uchc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Metersky, MD
Phone
860-679-3582
Email
metersky@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Oto
Organizational Affiliation
UConn Health, Adult Critical Care
Official's Role
Study Director
Facility Information:
Facility Name
UConn Health, John Dempsey Hospital
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Oto, PA-C
Phone
860-679-3107
Email
oto@uchc.edu
First Name & Middle Initial & Last Name & Degree
Mark Metersky, MD
Email
metersky@uchc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Early Antibiotics After Aspiration in ICU Patients
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