A Retrospective Study on Personalized Dosing Strategy of Patients Treated by Carbapenems: 2018-2021

Nanjing University

Status: Enrolling

Conditions: Bacterial Infections

Study type: Observational

Funder types: Other

Identifiers

NCT05762094

2022-504-01

Details and patient eligibility

About

Patients may benefit from the personalized carbapenem dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review and analyze the clinical outcomes of patients with different dosing strategy.

Full description

Rational use of carbapenem is closely associated with the clinical outcome of patients with infections. Serum concentration of carbapenem varies from different populations. The objective of this study is to describe the clinical outcome of patients with infection treated by carbapenem in China, regarding diagnosis, treatment and follow-up. It is a single-center, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, 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 Diagnosed as bacterial infection Treated by carbapenem Serum concentration determined during therapy

Exclusion criteria

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

Trial design

1,000 participants in 4 patient groups

CAR-R

Description:

Patients with impaired renal function (eGFR \< 60ml/min/1.73m2) treated by carbapenem

CAR-L

Description:

Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by carbapenem

CAR-LR

Description:

Patients with co-morbidity of both liver cirrhosis or impaired liver function (Child-Pugh grade B or C) and impaired renal function (eGFR \< 60ml/min/1.73m2) treated by carbapenem

CAR-N

Description:

Patients with normal liver function or renal function treated by carbapenem