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Prophylactic Antibiotics in Admitted Cirrhotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218695
Recruitment Status : Completed
First Posted : January 6, 2020
Results First Posted : August 31, 2022
Last Update Posted : March 3, 2023
Sponsor:
Collaborator:
American Association for the Study of Liver Diseases Foundation
Information provided by (Responsible Party):
Zachary Fricker, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Drug: Ceftriaxone Drug: Normal saline Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded placebo-controlled trial
Primary Purpose: Prevention
Official Title: A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
Actual Study Start Date : August 24, 2020
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : August 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization
 Drug: Ceftriaxone
Antibiotic
Other Name: Rocephin
Placebo Comparator: Placebo
Normal saline (50cc) once daily for up to one week or until end of hospitalization
 Drug: Normal saline
50cc intravenous once daily
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Infections [ Time Frame: For 7 days or until end of hospital stay ]
    Incident bacterial infection after enrollment


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: Up to 30 days ]
    Days in hospital after randomization

  2. Mortality [ Time Frame: Up to 30 days ]
    In-hospital

  3. 30-day Mortality [ Time Frame: Up to 30-days ]
    Includes f/u after discharge


Other Outcome Measures:
  1. Incident C Difficile Colitis [ Time Frame: 30 days ]
    Positive stool toxin/PCR with new onset diarrhea

  2. Incident ACLF [ Time Frame: During hospital admission up to 30 days ]
    (by NACSELD) or change in CLIF-C ACLF score

  3. Incident Variceal Hemorrhage [ Time Frame: During hospital admission up to 30 days ]
    Incident variceal hemorrhage

  4. Increase in MELD-Na [ Time Frame: Upon discharge (or at 30 days) ]
    >2 pts

  5. Fungal Infection [ Time Frame: During hospital admission up to 30 days ]
    Incident fungal infection (by culture data or requirement for new anti-fungal medication)

  6. Biomarker of Infection [ Time Frame: Once at time of randomization ]
    Procalcitonin

  7. Biomarker of Infection [ Time Frame: Once at time of randomization ]
    C-reactive protein


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218695


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
American Association for the Study of Liver Diseases Foundation
Investigators
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Principal Investigator: Zachary P Fricker, MD Beth Israel Deaconess Medical Center
  Study Documents (Full-Text)

Documents provided by Zachary Fricker, Beth Israel Deaconess Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] February 24, 2021
Informed Consent Form  [PDF] January 26, 2021

More Information
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Responsible Party: Zachary Fricker, Instructor, Division of Gastroenterology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04218695    
Other Study ID Numbers: 2020P000050
BIDMC-ABX-pilot-19 ( Other Identifier: Beth Israel Deaconess Medical Center )
First Posted: January 6, 2020    Key Record Dates
Results First Posted: August 31, 2022
Last Update Posted: March 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents