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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | December 31, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07612163 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.