Clinical trial NCT04218695: Prophylactic Antibiotics in Admitted Cirrhotics
Official title: A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis, Liver
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: American Association for the Study of Liver Diseases
First posted: 2020-01-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Infections
timeFrame: For 7 days or until end of hospital stay
Secondary outcomes:
measure: Length of Stay
timeFrame: Up to 30 days
measure: Mortality
timeFrame: Up to 30 days
measure: 30-day Mortality
timeFrame: Up to 30-days
Other outcomes:
measure: Incident C Difficile Colitis
timeFrame: 30 days
measure: Incident ACLF
timeFrame: During hospital admission up to 30 days
measure: Incident Variceal Hemorrhage
timeFrame: During hospital admission up to 30 days
measure: Increase in MELD-Na
timeFrame: Upon discharge (or at 30 days)
measure: Fungal Infection
timeFrame: During hospital admission up to 30 days
measure: Biomarker of Infection
timeFrame: Once at time of randomization
measure: Biomarker of Infection
timeFrame: Once at time of randomization
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Zachary P Fricker, MD
role: PRINCIPAL_INVESTIGATOR
References: