Early Antibiotics After Aspiration in ICU Patients

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UConn Health
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Cefepime; Ceftriaxone; Clavulanic Acid; Clavulanic Acids; Levofloxacin; Ofloxacin; Vancomycin

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