Back to resultsProphylactic Antibiotics in Admitted Cirrhotics
Primary Purpose
Cirrhosis, Liver
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ceftriaxone
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Cirrhosis, Liver
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
Infections
Incident bacterial infection after enrollment
Secondary Outcome Measures
Length of Stay
Days in hospital after randomization
Mortality
In-hospital
30-day Mortality
Includes f/u after discharge
Full Information
NCT ID
NCT04218695
First Posted
January 2, 2020
Last Updated
February 6, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Association for the Study of Liver Diseases Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04218695
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
August 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Association for the Study of Liver Diseases Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinded placebo-controlled trial
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline (50cc) once daily for up to one week or until end of hospitalization
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Other Intervention Name(s)
Rocephin
Intervention Description
Antibiotic
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Placebo
Intervention Description
50cc intravenous once daily
Primary Outcome Measure Information:
Title
Infections
Description
Incident bacterial infection after enrollment
Time Frame
For 7 days or until end of hospital stay
Secondary Outcome Measure Information:
Title
Length of Stay
Description
Days in hospital after randomization
Time Frame
Up to 30 days
Title
Mortality
Description
In-hospital
Time Frame
Up to 30 days
Title
30-day Mortality
Description
Includes f/u after discharge
Time Frame
Up to 30-days
Other Pre-specified Outcome Measures:
Title
Incident C Difficile Colitis
Description
Positive stool toxin/PCR with new onset diarrhea
Time Frame
30 days
Title
Incident ACLF
Description
(by NACSELD) or change in CLIF-C ACLF score
Time Frame
During hospital admission up to 30 days
Title
Incident Variceal Hemorrhage
Description
Incident variceal hemorrhage
Time Frame
During hospital admission up to 30 days
Title
Increase in MELD-Na
Description
>2 pts
Time Frame
Upon discharge (or at 30 days)
Title
Fungal Infection
Description
Incident fungal infection (by culture data or requirement for new anti-fungal medication)
Time Frame
During hospital admission up to 30 days
Title
Biomarker of Infection
Description
Procalcitonin
Time Frame
Once at time of randomization
Title
Biomarker of Infection
Description
C-reactive protein
Time Frame
Once at time of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary P Fricker, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Antibiotics in Admitted Cirrhotics
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