Prophylactic Antibiotics in Admitted Cirrhotics

Beth Israel Lahey Health

Status and phase: Completed; Phase 4

Conditions: Cirrhosis, Liver

Treatments: Drug: Ceftriaxone; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04218695

BIDMC-ABX-pilot-19 (Other Identifier)

2020P000050

Details and patient eligibility

About

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.

Full description

Cirrhosis is associated with a state of immune-compromise and progressive decompensation, acute on chronic liver failure (ACLF), and death are often caused by bacterial infections. Different sub-groups of patients with cirrhosis at increased risk, i.e. active upper gastrointestinal hemorrhage, low protein ascites, history of spontaneous bacterial peritonitis (SBP), are known to benefit from prophylactic antibiotics. The investigators hypothesize that hospitalized patients with advanced cirrhosis are also at increased risk and thus may benefit from preventive treatment. Subjects will be randomly assigned to receive an antibiotic vs placebo.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization

Treatment:

Drug: Ceftriaxone

Placebo

Placebo Comparator group

Description:

Normal saline (50cc) once daily for up to one week or until end of hospitalization

Treatment:

Drug: Normal saline