Clinical trial

Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration

Name

22-004-02

Description

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.

Trial arms

Trial start

2021-11-30

Estimated PCD

2024-12-01

Trial end

2024-12-30

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Antibiotics

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

Arms:

Antibiotics

Other names:

Augmentin

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

Arms:

Antibiotics

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 (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.

Arms:

Antibiotics

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

Arms:

Antibiotics

Size

100

Primary endpoint

ICU-free days

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-12-01

1 organization

5 products

2 indications

Organization

UConn Health

Product

Ceftriaxone

Indication

Aspiration

Indication