Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients

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

Patients may benefit from the personalized β-lactams dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review, prospective observe and analyze the clinical outcomes of patients with liver cirrhosis, and to build a population pharmacokinetics model in the population mentioned above.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: β-lactams

Detailed Description

Rational use of β-lactams is closely associated with the clinical outcome of patients with infections. Serum concentration of β-lactams varies from different populations. The objective of this study is to describe the clinical outcome of cirrhotic patients with infection treated by β-lactams in China, regarding diagnosis, treatment and follow-up. It is a single-center, retro-prospective, observational study. Inclusion criteria are an age ≥ 18, liver cirrhosis, diagnosed as bacteria infection and serum concentration must be determined during therapy. Data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. A descriptive analysis will be performed.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Dayu Chen; Phone Number: +862583106666; Email: cdy_pharmacy@njglyy.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Dayu Chen; Phone Number: +862583106666; Email: cdy_pharmacy@njglyy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese adult cirrhotic patients with bacterial infections treated by β-lactams

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cirrhotic patients treated by β-lactams; Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by β-lactams	Drug: β-lactams; Participants receiving β-lactams were included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	30-day mortality and 90-day mortality	January 2018-December 2026
Serum concentrations	Serum concentrations of β-lactams	January 2018-December 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients reach clinical response at end of treatment	By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12*10^9/L or less than 4*10^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms	January 2018-December 2026
Proportion of patients reach clinical response at day 4 of treatment	By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12*10^9/L or less than 4*10^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms	January 2018-December 2026
Daily Sequential Organ Failure Assessment score change	Sequential Organ Failure Assessment score (Range from 0-24), lower score means a better outcome. Increase of 2 points within 48 hours means the presence of sepsis.	January 2018-December 2026
Incidence of Septic Shock	Incidence of Septic Shock	January 2018-December 2026
Safety outcome measures	Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of β-lactams	January 2018-December 2026

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Principal Investigator: Dayu Chen, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bacterial Infections; Liver cirrhosis; β-lactam
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Digestive System Diseases; Liver Diseases; Bacterial Infections and Mycoses; Fibrosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis; Bacterial Infections
• Other Study ID Numbers: 2023-298-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No