Prophylactic Antibiotics in Admitted Cirrhotics

Cirrhosis, Liver Clinical Trial

Official title:

A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218695
• Other study ID #: 2020P000050
• Secondary ID: BIDMC-ABX-pilot-
• Status: Completed
• Phase: Phase 4
• Start date: August 24, 2020
• Est. completion date: August 28, 2021

Study information

• Verified date: February 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 28, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Ceftriaxone
Antibiotic
• Normal saline
50cc intravenous once daily

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	American Association for the Study of Liver Diseases Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incident C Difficile Colitis	Positive stool toxin/PCR with new onset diarrhea	30 days
Other	Incident ACLF	(by NACSELD) or change in CLIF-C ACLF score	During hospital admission up to 30 days
Other	Incident Variceal Hemorrhage	Incident variceal hemorrhage	During hospital admission up to 30 days
Other	Increase in MELD-Na	>2 pts	Upon discharge (or at 30 days)
Other	Fungal Infection	Incident fungal infection (by culture data or requirement for new anti-fungal medication)	During hospital admission up to 30 days
Other	Biomarker of Infection	Procalcitonin	Once at time of randomization
Other	Biomarker of Infection	C-reactive protein	Once at time of randomization
Primary	Infections	Incident bacterial infection after enrollment	For 7 days or until end of hospital stay
Secondary	Length of Stay	Days in hospital after randomization	Up to 30 days
Secondary	Mortality	In-hospital	Up to 30 days
Secondary	30-day Mortality	Includes f/u after discharge	Up to 30-days