Early Antibiotics After Aspiration in ICU Patients

UConn Health

Status and phase: Terminated; Phase 4

Conditions: Aspiration; Aspiration Pneumonia

Treatments: Drug: Levofloxacin; Drug: Amoxicillin clavulanic acid; Drug: Ceftriaxone; Drug: Cefepime; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05079620

22-004-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Antibiotics

Experimental group

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.

Treatment:

Drug: Vancomycin

Drug: Cefepime

Drug: Ceftriaxone

Drug: Amoxicillin clavulanic acid

Drug: Levofloxacin

Control

No Intervention group

Description:

No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.