A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
Overview
- Phase
- Phase 4
- Intervention
- Ceftriaxone
- Conditions
- Cirrhosis, Liver
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Infections
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Zachary Fricker
Instructor, Division of Gastroenterology
Beth Israel Deaconess Medical Center
Eligibility 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
Arms & Interventions
Treatment
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Intervention: Ceftriaxone
Placebo
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Intervention: Normal saline
Outcomes
Primary Outcomes
Infections
Time Frame: For 7 days or until end of hospital stay
Incident bacterial infection after enrollment
Secondary Outcomes
- Length of Stay(Up to 30 days)
- Mortality(Up to 30 days)
- 30-day Mortality(Up to 30-days)