Title
Prophylactic Antibiotics in Admitted Cirrhotics
A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
Phase
Phase 4Lead Sponsor
Harvard UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Cirrhosis, LiverIntervention/Treatment
Ceftriaxone ...Study Participants
32In 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.
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.
50cc intravenous once daily
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Normal saline (50cc) once daily for up to one week or until end of hospitalization
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
| Event Type | Organ System | Event Term | Treatment | Placebo |
|---|
Incident bacterial infection after enrollment
Days in hospital after randomization
In-hospital
Includes f/u after discharge
Positive stool toxin/PCR with new onset diarrhea
(by NACSELD) or change in CLIF-C ACLF score
Incident variceal hemorrhage
>2 pts
Incident fungal infection (by culture data or requirement for new anti-fungal medication)
Procalcitonin
C-reactive protein
