Phase 4
Completed N=32
Prophylactic Antibiotics in Admitted Cirrhotics
Cirrhosis, Liver
Source: ClinicalTrials.gov NCT04218695 ↗
Enrolled (actual)
32
Serious AEs
25.0%
Results posted
Aug 2022
Primary outcomePrimary: Infections — 2; 5 Participants
◆ Published Evidence
Emerging
4citations · ~2 / year
A randomized study of ceftriaxone for the prevention of infections in hospitalized patients with advanced cirrhosis.
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.
Linked Publications
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A randomized study of ceftriaxone for the prevention of infections in hospitalized patients with advanced cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infections |
2; 5 | — |
| SECONDARY Length of Stay |
9; 10 | — |
| SECONDARY Mortality |
1; 4 | — |
| SECONDARY 30-day Mortality |
2; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04218695) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.