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

N

Nanjing University

Status

Enrolling

Conditions

Bacterial Infections

Treatments

Drug: β-lactams

Study type

Observational

Funder types

Other

Identifiers

NCT07612163
2023-298-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Cirrhotic patients treated by β-lactams
Description:
Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by β-lactams
Treatment:
Drug: β-lactams

Trial contacts and locations

1

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Central trial contact

Dayu Chen

Data sourced from clinicaltrials.gov

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