NCT04218695

Prophylactic Antibiotics in Admitted Cirrhotics

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
DRUG	Ceftriaxone	Antibiotic
DRUG	Normal saline	50cc intravenous once daily

Timeline

• Start date: 2020-08-24
• Primary completion: 2021-05-31
• Completion: 2021-08-28
• First posted: 2020-01-06
• Last updated: 2023-03-03
• Results posted: 2022-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study