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

NCT07612163 | Recruiting DMC

• 1 other identifier: 2023-298-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Infections

Keywords

β-lactam; Bacterial Infections; Liver cirrhosis

Outcome Measures

Primary Outcomes (2)

• Mortality

  30-day mortality and 90-day mortality

  January 2018-December 2026

• Serum concentrations

  Serum concentrations of β-lactams

  January 2018-December 2026

Secondary Outcomes (5)

• Proportion of patients reach clinical response at end of treatment

  January 2018-December 2026

• Proportion of patients reach clinical response at day 4 of treatment

  January 2018-December 2026

• Daily Sequential Organ Failure Assessment score change

  January 2018-December 2026

• Incidence of Septic Shock

  January 2018-December 2026

• Safety outcome measures

  January 2018-December 2026

Study Arms (1)

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

Interventions

β-lactams DRUG

Participants receiving β-lactams were included.

Cirrhotic patients treated by β-lactams

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Bacterial Infections; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dayu Chen

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dayu Chen

CONTACT

+862583106666; cdy_pharmacy@njglyy.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist in Charge

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: December 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (1)