Clinical trial Recruiting at 1 site Observational Ages 18 and up

Personalized beta-lactam dosing in cirrhosis patients with bacterial infections

Official title: Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study

Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07612163 · Data updated 2026-11-12

This study tests whether tailoring beta-lactam dosing based on patient liver disease and drug levels can help people with cirrhosis and bacterial infections.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Academic / other
Locations1 site (Nanjing, Jiangsu)
StatusRecruiting
StartedDecember 31, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedMay 28, 2026
Trial IDNCT07612163 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with liver cirrhosis and confirmed bacterial infection who are treated with beta-lactams and have serum drug concentrations measured during therapy, at a single center in Nanjing, China.

Probably not a fit

Patients whose infections resolve independently of dosing adjustments or who do not have pharmacokinetic measurements may not benefit from population PK-informed dosing.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, retro-prospective observational study in China that will describe how cirrhotic patients with bacterial infections respond to beta-lactam antibiotics. Researchers will collect data on clinical presentation, laboratory results, treatments, and follow-up to build a population pharmacokinetics model. The study includes adults with cirrhosis who receive beta-lactams and have serum drug concentrations measured during therapy. A descriptive analysis will be performed to explore associations between drug levels, dosing, and outcomes. The goal is to support more personalized dosing strategies in this high-risk population.

Why it matters

Potential benefit: If successful, patients with cirrhosis and bacterial infections could receive more effective and safer beta-lactam dosing based on pharmacokinetic modeling.

How similar studies have gone: Similar pharmacokinetic studies in special populations have informed dosing, but this precise cirrhosis-focused, retrospective-prospective model is relatively novel in this setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Age over 18 years Chinese patient: male or female Liver cirrhosis Diagnosed as bacterial infection Treated by β-lactams Serum concentration determined during therapy

Exclusion Criteria:

Duration of β-lactams treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of β-lactams

Where it's running

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Nanjing, Jiangsu, China
    Recruiting

Study contacts

  • Principal investigator: Dayu Chen — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Study coordinator: Dayu Chen
  • Email: cdy_pharmacy@njglyy.com
  • Phone: +862583106666

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.