PK/PD of Caspofungin in Children Severe Infection

Fudan University

Status: Enrolling

Conditions: Infection, Fungal; Pharmacokinetics

Treatments: Drug: Caspofungin

Study type: Observational

Funder types: Other

Identifiers

NCT04961593

fdpicu-24

Details and patient eligibility

About

Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.

Full description

The current international recommended dose of caspofungin is 70 mg per square metre for load for children who is older than three months of age, followed by 50 mg per square metre for maintenance. For newborns and infants younger than 3 months of age，25 mg per square metre is also recommended.

Whether such a recommended dose can achieve an ideal PK/PD target in children with liver insufficiency, hypoproteinemia, ECMO treatment, or severe infection is still lacking in sufficient clinical data.

The objective of this study is to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.

Blood sampling time points of caspofungin are listed as follow:

Before administration (0 min); 1 h, 2 h, 4 h, 8 h , 12 h and 24 h after administration.

The concentration of caspofungin in whole blood will be analyzed at Huashan Hospital of Fudan University.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children receiving caspofungin in pediatric intensive care unit

Exclusion criteria

• No Informed Consent signed Participate in other clinical trials

Trial design

60 participants in 1 patient group

Treatment group

Description:

Children treated with caspofungin in the pediatric intensive care unit

Treatment:

Drug: Caspofungin