Prophylactic Antibiotics in Admitted Cirrhotics

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-24

Study Completion Date

2021-08-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Empirical vs 2nd Line Antibiotic Therapy in Health-care Associated Infections in Cirrhosis

NCT01820026

Cirrhosis

UNKNOWN PHASE4

International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections

NCT06634940

Cirrhosis Bacterial Infections Multidrug Resistance

RECRUITING

Rifaximin and Norfloxacin for Prevention of SBP in Adults With Decompensated Cirrhosis

NCT03695705

Cirrhosis, Liver

COMPLETED PHASE3

Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

NCT02717273

Liver Transplantation Surgical Site Infection

COMPLETED PHASE3

Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis

NCT04395365

Spontaneous Bacterial Peritonitis

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cirrhosis, Liver

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded placebo-controlled trial

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

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

Group Type EXPERIMENTAL

Ceftriaxone

Intervention Type DRUG

Antibiotic

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

50cc intravenous once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ceftriaxone

Antibiotic

Intervention Type DRUG

Normal saline

50cc intravenous once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rocephin Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No