Trial Outcomes & Findings for Early Antibiotics After Aspiration in ICU Patients (NCT NCT05079620)

Results Overview

Number of days not spent in the ICU, between date of admission and 30 days afterwards. Death or discharge can both reduce this measure.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

From admission to 30 days, death, or hospital discharge, whichever occurs first

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 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 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 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 (AUC/MIC) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. Levofloxacin: At any point after 24 hr, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg q 24 hours for the remainder of 5 days	Control No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotics n=2 Participants 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. 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 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 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 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 (AUC/MIC) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. 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	Control n=3 Participants No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.	Total n=5 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 4.2 • n=2 Participants	76.7 years STANDARD_DEVIATION 19.4 • n=3 Participants	72.8 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=2 Participants	1 Participants n=3 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=2 Participants	2 Participants n=3 Participants	3 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Intubated prior to enrollment	1 Participants n=2 Participants	1 Participants n=3 Participants	2 Participants n=5 Participants
Chronic tracheostomy	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants n=5 Participants
Current steroid use at time of enrollment	0 Participants n=2 Participants	1 Participants n=3 Participants	1 Participants n=5 Participants
Witnessed aspiration event, prior to admission	0 Participants n=2 Participants	1 Participants n=3 Participants	1 Participants n=5 Participants
Days between hospital admission and enrollment	0 days STANDARD_DEVIATION 0 • n=2 Participants	2 days STANDARD_DEVIATION 3.5 • n=3 Participants	1.2 days STANDARD_DEVIATION 2.7 • n=5 Participants
Pneumonia diagnosed prior to enrollment	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants n=5 Participants
Positive serum ethanol at time of admission	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants n=5 Participants
Positive sputum culture prior to enrollment	0 Participants n=2 Participants	0 Participants n=3 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Antibiotics n=2 Participants 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. 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 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 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 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 monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. Levofloxacin: At any point after 24 hours, clinicians may transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg q24 hours for the remainder of 5 days	Control n=3 Participants No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.
ICU-free Days	14 days Standard Deviation 14.1	18.7 days Standard Deviation 16.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Antibiotics n=2 Participants 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. 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 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 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 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 monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. Levofloxacin: At any point after 24 hours, clinicians may transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg q24 hours for the remainder of 5 days	Control n=3 Participants No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.
Ventilator-free Days	19 days Standard Deviation 15.6	20 days Standard Deviation 17.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Antibiotics n=2 Participants 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. 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 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 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 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 monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if negative. Levofloxacin: At any point after 24 hours, clinicians may transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg q24 hours for the remainder of 5 days	Control n=3 Participants No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.
Hospital-free Days	9 days Standard Deviation 12.7	14.7 days Standard Deviation 13.7

SECONDARY outcome

Timeframe: 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.