Clinical trial NCT04961593: PK/PD of Caspofungin in Children Severe Infection
Official title: Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pharmacokinetics
Infection, Fungal
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children receiving caspofungin in pediatric intensive care unit including but not limited to children with liver insufficiency, hypoproteinemia, ECMO treatment, CRRT treatment or sepsis.

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Children receiving caspofungin in pediatric intensive care unit

Exclusion Criteria:

* No Informed Consent signed Participate in other clinical trials

Primary outcomes:
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
timeFrame: Day 1-5
Secondary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
timeFrame: Day 1-5
measure: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter
timeFrame: Day1-5
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter
timeFrame: Day1-5
measure: Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter
timeFrame: Day1-5
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Guoping Lu, doctor
role: PRINCIPAL_INVESTIGATOR
References: