NCT04218695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 31, 2022

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 2, 2020

Results QC Date

August 8, 2022

Last Update Submit

February 6, 2023

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Infections

    Incident bacterial infection after enrollment

    For 7 days or until end of hospital stay

Secondary Outcomes (3)

  • Length of Stay

    Up to 30 days

  • Mortality

    Up to 30 days

  • 30-day Mortality

    Up to 30-days

Other Outcomes (7)

  • Incident C Difficile Colitis

    30 days

  • Incident ACLF

    During hospital admission up to 30 days

  • Incident Variceal Hemorrhage

    During hospital admission up to 30 days

  • +4 more other outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

1 gram intravenous ceftriaxone once daily for up to one week or until end of hospitalization

Drug: Ceftriaxone

Placebo

PLACEBO COMPARATOR

Normal saline (50cc) once daily for up to one week or until end of hospitalization

Drug: Normal saline

Interventions

CeftriaxoneDRUG

Antibiotic

Also known as: Rocephin
Treatment
Normal salineDRUG

50cc intravenous once daily

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MELD-Na \>= 18
  • Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Fricker Z, Jiang G, Patel H, McLaughlin A, Izunza Barba S, Niezen S, Curry M. A randomized study of ceftriaxone for the prevention of infections in hospitalized patients with advanced cirrhosis. Hepatol Commun. 2024 Jan 5;8(1):e0356. doi: 10.1097/HC9.0000000000000356. eCollection 2024 Jan 1.

    PMID: 38180983DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

CeftriaxoneSaline Solution

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Zachary Fricker
Organization
BIDMC
zfricker@bidmc.harvard.edu
6176321070

Study Officials

  • Zachary P Fricker, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded placebo-controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor, Division of Gastroenterology

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 6, 2020

Study Start

August 24, 2020

Primary Completion

May 31, 2021

Study Completion

August 28, 2021

Last Updated

March 3, 2023

Results First Posted

August 31, 2022

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)