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Completed

NCT Number: NCT04218695

Prophylactic Antibiotics in Admitted Cirrhotics

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftriaxone

Drug

Antibiotic

Other names: Rocephin

normal saline

Drug

50cc intravenous once daily

Other names: Placebo

Primary outcomes

  1. Infections

    Time frame: For 7 days or until end of hospital stay

    Incident bacterial infection after enrollment

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • American Association for the Study of Liver Diseases

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2020
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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