Actively Recruiting
Study of Beta-Lactam Antibiotic Effects and Drug Levels in Adults With Liver Cirrhosis and Bacterial Infections
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-05-28
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the clinical outcomes and population pharmacokinetics of beta-lactam antibiotics in patients with liver cirrhosis who have bacterial infections. The study focuses on how serum concentrations of beta-lactams vary among this specific population and how these variations relate to the effectiveness of treatment. It is a single-center, retro-prospective observational study conducted in China, including patients aged 18 and older. Participants include cirrhotic patients treated with beta-lactams, with a focus on those with impaired liver function classified as Child-Pugh grade B or C. The study involves retrospectively reviewing past data and prospectively observing ongoing cases. Data collected includes clinical presentations, biological samples, treatment details, and follow-up information. The study also aims to build a population pharmacokinetics model for beta-lactams in this group. During the study, researchers will assess mortality rates and serum concentrations of beta-lactams from January 2018 to December 2026. They will also evaluate clinical responses at the end and on day 4 of treatment, changes in organ failure scores, incidence of septic shock, and safety outcomes. Participants treatments and health status will be monitored through biological testing and clinical assessments over this period to better understand the therapys impact.
CONDITIONS
Brief Title
Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients
Research Team
D
Dayu Chen
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