Actively Recruiting
Clinical Efficacy and Population Pharmacokinetics of Beta-Lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study
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
On this page
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 therapy's impact.
CONDITIONS
Brief Title
Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Chinese patient: male or female
- Diagnosed with liver cirrhosis
- Diagnosed with bacterial infection
- Treated with beta-lactam antibiotics
- Serum concentration determined during therapy
You will not qualify if you...
- Beta-lactam treatment duration less than 48 hours
- Kidney or liver function not tested before treatment started
- Using more than two kinds of beta-lactam antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 48 hours during infection treatment
Participants receive beta-lactam antibiotics for their bacterial infection while living with liver cirrhosis. The treatment is observed to evaluate clinical outcomes and serum drug concentrations.
Visits as part of routine clinical care during treatment
Duration - Up to December 2026
Participants are monitored after treatment to assess clinical response, organ function changes, septic shock incidence, and safety outcomes.
Additional visits may occur depending on clinical needs
Trial Site Locations
Total: 1 location
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
D
Dayu Chen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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