Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT04218695
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Antibiotic
Other names: Rocephin
50cc intravenous once daily
Other names: Placebo
Time frame: For 7 days or until end of hospital stay
Incident bacterial infection after enrollment
Time frame: Up to 30 days
Days in hospital after randomization
Time frame: Up to 30 days
In-hospital
Time frame: Up to 30-days
Includes f/u after discharge
Time frame: 30 days
Positive stool toxin/PCR with new onset diarrhea
Time frame: During hospital admission up to 30 days
(by NACSELD) or change in CLIF-C ACLF score
Time frame: During hospital admission up to 30 days
Incident variceal hemorrhage
Time frame: Upon discharge (or at 30 days)
>2 pts
Time frame: During hospital admission up to 30 days
Incident fungal infection (by culture data or requirement for new anti-fungal medication)
Time frame: Once at time of randomization
Procalcitonin
Time frame: Once at time of randomization
C-reactive protein
Beth Israel Deaconess Medical Center
Other
A Pilot Study of the Effect of Prophylactic Antibiotics on Hospitalized Patients With Advanced Cirrhosis
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