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Prophylactic Antibiotics in Admitted Cirrhotics

NCT04218695 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-03-03

Study results available
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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.

Conditions

  • Cirrhosis, Liver

Interventions

DRUG

Ceftriaxone

Antibiotic

DRUG

Normal saline

50cc intravenous once daily

Sponsors & Collaborators

Principal Investigators

  • Zachary P Fricker, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2021-05-31
Completion
2021-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218695 on ClinicalTrials.gov