Prophylactic Antibiotics in Admitted Cirrhotics

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. Specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics vs placebo.

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

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: American Association for the Study of Liver Diseases Foundation
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ceftriaxone

Criteria

Inclusion Criteria:

• MELD-Na >= 18

• Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies

Exclusion Criteria:

• Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)

• Allergy to cephalosporins

• Pregnancy (due to limited prospective data regarding safety of ceftriaxone)

• Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection

• Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)

• H/o recurrent C difficile infection within the past year (>2) or requiring fecal microbiota transplant (FMT)

• Enrollment in the study protocol during a previous admission